Zada L. Giles, Investigator
Contents
1. 2 In the Lab Room several different products can be weighed and staged for mixing on the same counter top For example on 05 12 15 we observed pre printed worksheets and labeling for different products on the counter where production takes place There is no separation for these materials which can lead to a mix up of labeling or components Also multiple products can be taken into the Clean Room simultaneously for aseptic filling 3 On 05 12 15 1 IV bag of 0 9 Sodium Chloride solution and 1 FV bag of Sterile Water for Injection were observed in the sink in the Ante Room These bags had no additional labeling to determine if the firm had used them in processing or was going to use them and no indication of what product these solutions would be used for OBSERVATION 11 There is no quality control unit Specifically Your firm has not established a quality control unit with the responsibility to approve or reject all components containers closures packing material labeling and drug products For example 1 Containers and closures are not examined upon receipt to ensure they meet specifications for use 2 No finished product testing is performed on drug products intending to be sterile before release for distribution 3 Your firm has just recently established a complaint file A review of your firm s Incident Report Forms found no investigations were performed for complaints to determine root cause For example a2. CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products SSeS BS PSS OS ee a OBSERVATION 12 Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product Specifically roducts intended to be sterile OBSERVATION 13 Routine calibration of equipment is not performed according to a written program designed to assure proper performance Specifically There are no records to demonstrate the following equipment has been calibrated for use 1 The pressure gauge used for the filter integrity testing of the B Braun 0 2m filter used for aseptic filling 2 The scale in the Lab Room used to weigh ingredients used in production of drug products 3 The thermometer in the incubator used to test environmental samples and finished product 4 The thermometer used in the depyrogenation oven used for glassware 5 The thermometer in the autoclave used to sterilize glassware and terminally sterilize injectable drug products OBSERVATION 14 Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications without performing at least one specific identity test on each component and establishing the reliability of the supplier s analyses through appropriate validation of the supplier s test results at ap
3. when needed throughout the filling process and allow to dry On 05 12 15 a technician was observed spraying her gloves EMPLOYEE S SIGNATURE Zada L Giles Investigator Ze Marvin D Jones Investigator mps SEE REVERSE OF THIS PAGE DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION 404 BNA Dr Bldg 200 Ste 500 O5712 2015 05 21 2015 Nashville TN 37217 2597 oe 615 366 7801 Fax 615 366 7802 3011504027 Industry Information www fda gov oc industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products with sterile IPA 70 but not allowing the alcohol to dry before processing The technician was aseptically filling Morphine 10 mg ml Intrathecal Solution lot 05122015 6 Morphine 20 mg ml Intrathecal Solution lot 05122015 17 and Methylcobalamin 1 000 mcg ml injection lot 05122015 14 Your firm s SOP 7 011 Gowning and Gloving states technicians will wash forearms and hands from the elbows down before gowning to enter the clean room On 05 12 15 we observed a technician washing only her hands and did not wash past the wrist
4. On 3 4 25 your firm received a complaint for Neurogenic XR BAC GAB cream being sticky No lot number was recorded on the Pharmacy Incident Report Form and you did not request that the product be returned for analysis No investigation was performed and the corrective action was to remake the product and send the patient a new jar b On 03 06 15 your firm received a complaint for Anti Inflammatory Plus 10 pain gel that had separated upon the patient receiving the product No lot number was recorded on the Pharmacy Incident Report Form and you did not request that the product be returned for analysis No investigation was performed and the corrective action was to remake the product and send the patient a new jar EMPLOYEE S SIGNATURE Zada L Giles Investigator Marvin D Jones Investigator mod SEE REVERSE OF THIS PAGE FORM FDA 483 09 08 PREVIOUS EDITION OBSOLETE so INSPECTIONAL OBSERVATIONS PAGE 7 OF 10 PAGES 05 21 2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION 404 BNA Dr Bidg 200 Ste 500 i 05 12 2015 05 21 2015 Nashville TN 37217 2597 roe 3011504027 615 366 7801 Fax 615 366 7802 Industry Information www fda gov oc industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A
5. gt DEPARTMENT OF HEALTH AND HUMAN SERVICES 4 FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION 05 12 2015 05 21 2015 FEI NUMBER 3011504027 The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products This document lists observations made by the FDA representative s during the inspection of your facility They are inspectional observations and do not represent a final Agency determination regarding your compliance If you have an objection regarding an observation or have implemented or plan to implement corrective action in response to an observation you may discuss the objection or action with the FDA representative s during the inspection or submit this information to FDA at the address above If you have any questions please contact FDA at the phone number and address above 404 BNA Dr Bldg 200 Ste 500 Nashville TN 37217 2597 615 366 7801 Fax 615 366 7802 Industry Information www fda gov oc industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS DURING AN INSPECTION OF YOUR FIRM WE OBSERVED OBSERVATION 1 Each batch of drug product purporting to be sterile and pyrogen free is not laboratory tested to determine confor
6. in an ISO classified area 4 Smoke studies for qualification of the ISO 5 area where injectable drug products are processed were not documented with diagram or video EMPLOYEE S SIGNATURE Zada L Giles Investigator Marvin D Jones Investigator OA SEE REVERSE OF THIS PAGE ORM EDA 43 0905 _____meviusemmovonsous _____INSPECTIONALOBSERVATIONS 2 40F 0 PAGS 05 21 2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION 05 12 2015 05 21 2015 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED FE NUMBER 3011504027 TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A 404 BNA Dr Bldg 200 Ste 500 Nashville TN 37217 2597 615 366 7801 Fax 615 366 7802 Industry Information www fda gov oc industry CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products OBSERVATION 6 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions Specifically 1 Your firm s daily cleaning of the Clean Room and Ante Room consists of wiping the walls and floors with a non sterile Swiffer brand mop On a monthly basis your firm cleans with Lysol IC and Clorox Hydrogen Peroxide
7. ED Nashville TN 37217 2597 a 3011504027 1 TO Vincent Matthew Poteet Owner Pharmacist OBSERVATION 3 615 366 7801 Fax 615 366 7802 FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed Specifically 1 Your firm has not validated your sterilization process for autoclaving glass vials to be used for drugs products intending to be sterile Your firm has not validated your filter sterilization process using a 0 2m filter to aseptically fill injectable drugs purporting to be sterile Furthermore the user manual for the filter your firm is using states this filter is not intended for intrathecal drug administration Your firm has been using this filter since 2012 to aseptically fill injectable drugs purporting to be sterile including intrathecal solutions Your firm has not validated your process of depyrogenating glassware used in the mixing of drug products to be aseptically filled or terminally sterilized Your firm s SOP 7 011 Gowning and Gloving states that gloves will be disposed of upon leaving the Clean Room and a new pair donned to retum On 05 12 15 we observed a technician leave the Clean Room to retrieve a syringe from the Ante Room The firm s owner who was not wearing gloves had placed t
8. IRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A Clothing of personnel engaged in the manufacturing processing and packing of drug products is not appropriate for the duties they perform Specifically 1 Non sterile gowns face masks and hair covers are used during the production of drug products intended to be sterile These garments are stored in open containers in the Ante Room 2 On 05 12 15 we observed the processing of Morphine 10 mg ml Intrathecal Solution lot 05122015 6 Morphine 20 mg ml Intrathecal Solution lot 05122015 17 and Methylcobalamin 1 000 mcg ml injection lot 05122015 14 all purporting to be sterile The technician s gown did not adequately cover the technician leaving the collar of her shirt and her neck area exposed Also the technicians forehead and eyes were not covered and her hair was loose from her hair cover around the back of her neck 3 On 05 12 15 we observed a technician mixing and filling Lidocaine 2 gel lot 05122015 15 for intrathecal use into glass vials to be autoclaved The technician was wearing gloves but not wearing any gowning or head face covers over her street clothes This process was taking place in the Lab Room which is an unclassified room with no HEPA filtration OBSERVATION 9 Results of stability testing are not used in determining expiration dates Specifically Your firm has not conducted any s
9. LTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION 404 BNA Dr Bldg 200 Ste 500 Nashville TN 37217 2597 615 366 7801 Fax 615 366 7802 Industry Information www fda gov oc industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products Zada L Giles Investigator se aaa Marvin D Jones Investigator f WAypy T 05 21 2015 PAGE 10 OF 10 PAGES FORM FDA 483 09
10. before gowning and entering the Clean Room to aseptically fill Morphine 10 mg ml Intrathecal Solution lot 05122015 6 Morphine 20 mg ml Intrathecal Solution lot 405122015 17 and Methylcobalamin 1 000 mcg ml injection lot 05122015 14 Your firm s SOP 4 004 Incubator Temperature Monitoring does not establish continuous monitoring or give procedures for investigating out of range temperatures This incubator is used to incubate media fills environmental monitoring samples and finished product microbial testing Temperature of the incubator is recorded once daily During a record review for the past year of the Incubator Temperature log it was noted the temperature went out of range approximately 30 of the time No investigations were performed Your firm does not perform positive or negative controls on media which is used for sterility testing on products and environmental monitoring Your firm does not perform growth promotion testing on media used for microbial testing On 05 12 15 we observed one of the firm s owners pharmacists chewing gum in the Lab Room while Lidocaine 2 gel lot 05122015 15 for intrathecal use was being produced On 05 12 15 a technician was observed placing her hands between the product and air flow during processing This obstruction could cause turbulent air flow around the product being aseptically filled OBSERVATION 4 Aseptic processing areas are deficient regarding the
11. between the light fixture and the ceiling that would allow for a build up of dirt and debris OBSERVATION 7 There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed Specifically A review of records from the past year found Sufentanil 50mcg ml Intrathecal Solution lot 01102014 24 Morphine 50 mg ml Intrathecal Solution lot 06252014 6 and Morphine 40 mg ml Fentanyl 2 000 mcg ml Intrathecal solution lot 08062014 19 all tested positive for microbial contamination No investigations were performed and the lots were EMPLOYEE S SIGNATURE Zada L Giles Investigator F Marvin D Jones Investigator nos SEE REVERSE OF THIS PAGE 05 21 2015 INSPECTIONAL OBSERVATIONS FORM FDA 483 09 08 PAGE 5 OF 10 PAGES kd DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION Industry Information www fda gov oc industry CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products 404 BNA Dr Bldg 200 Ste 500 05 12 2015 05 21 2015 Nashville TN 37217 2597 ae 3011504027 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO Vincent Matthew Poteet Owner Pharmacist distributed OBSERVATION 8 615 366 7801 Fax 615 366 7802 F
12. he Lab room approximately 70 of the time the Clean Room approximately 18 of the time and the Ante Room approximately 98 of the time No investigations were performed into these discrepancies 2 During a review of temperature and humidity logs from the past year Jan 2014 May 2015 it was found the humidity was out of range for the Lab Room approximately 13 of the time the Clean Room approximately 63 of the time and the Ante Room approximately 14 of the time No investigations were performed into these discrepancies 3 Temperature and humidity in aseptic processing areas are not continuously monitored The gauge readings are only documented once daily OBSERVATION 16 Batch production and control records do not include complete information relating to the production and control of each batch Specifically 1 Your firm s Logged Formula Worksheets do not contain a representative label from the product that was produced 2 Your firm s Logged Formula Worksheets do not indicate which containers and closures were used or what container the product was filled into 3 Heating and mixing times during production are not documented in the Logged Formula Worksheets EMPLOYEE S SIGNATURE Zada L Giles Investigator oy Marvin D Jones Investigator SEE REVERSE OF THIS PAGE FORM FDA 483 __ PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 9 OF 10 PAGES 05 21 2015 DEPARTMENT OF HEA
13. he syringe in the Ante Room for the technician without wiping down the syringe The technician did not change gloves before beginning aseptic filling Your firm s SOP 8 012 Compounding Sterile Solutions states to produce all injectables in a Class 100 environment On 05 12 15 we observed Lidocaine 2 gel lot 05122015 15 to be used in an intrathecal pump Morphine 10 mg ml Intrathecal Solution lot 05122015 6 Morphine 20 mg ml Intrathecal Solution lot 05122015 17 and Methylcobalamin 1 000 mcg ml injection lot 05122015 14 being compounded in the Lab Room which is an unclassified room that does not have HEPA filtration Your firm s SOP 7 007 3 Media Fill for High Risk Compounding states that media fill tests are to be performed semi annually for each technician in an ISO class 5 area however this does not simulate your firm s actual process because all drug products are produce in the Lab Room which is an unclassified area with no HEPA filtration Your firm s SOP 7 011 Gowning and Gloving does not have requirements for complete covering of the facial area On 05 12 15 we observed an employee aseptically filling Morphine 10 mg ml Intrathecal Solution lot 05122015 6 Morphine 20 mg ml Intrathecal Solution lot 05122015 17 and Methylcobalamin 1 000 mcg ml injection lot 05122015 14 with exposed forehead and eyes Your firm s SOP 7 011 Gowning and Gloving states the technician will spray gloves with sterile IPA 70
14. in the Clean Room and Ante Room Your firm does not use any sporicide while cleaning in the Clean Room This cleaning method and schedule is inadequate for cleaning and disinfecting a room for aseptic processing Also cleaning products used are not documented on cleaning logs 2 You do not use a sporicide in your ISO 5 hood where aseptic filling takes place The only product used to clean the ISO 5 hood is sterile 70 Isopropyl Alcohol 3 On 05 12 15 we observed stacked plastic baskets containing in process drug product and aseptic filling equipment pre packaged syringes and filters The technician took these stacked baskets into the Ante Room and did not wipe the baskets or materials down before entering Once the technician completed gowning she carried the baskets into the Clean Room for aseptic processing The materials were wiped with a non sterile pre wetted alcohol wipe before being placed in the ISO 5 hood These wipes are in a re sealable container via sticky flap located on the top 4 During the inspection visible dirt and debris was observed on the return vent in the clean room and Swiffer mops used in the Clean Room and Ante Room were propped up against the walls in each room with the mop end leaning against the wall Also it was noted the Clean Room Ante Room and Lab Room all had open trash receptacles 5 The lighting in the Clean Room is not recessed into the ceiling and there is a visible gap
15. mance to such requirements Specifically 1 Microbial testing is not performed for each lot of drug product purporting to be sterile Your firm s lots range in volume from 1 mL to 2400 mL Furthermore you have not validated your microbial testing method 2 No endotoxin testing is performed on finished product and vials and stoppers are not depyrogenated before use All drug products your firm produces are made from non sterile components OBSERVATION 2 Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use Specifically Your firm does not depyrogenate any containers or closures used in the aseptic filling terminal sterilization of drugs products intending to be sterile EMPLOYEE S SIGNATURE Zada L Giles Investigator O Marvin D Jones Investigator Mass SEE REVERSE OF THIS PAGE FORM FDA 483 09 08 PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS _ x PAGE 1 OF 10 PAGES 05 21 2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES gt i FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION Industry Information www fda gov oc industry CITY STATE ZIP CODE COUNTRY TYPE ABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products t 404 BNA Dr Bldg 200 Ste 500 05 12 2015 05 21 2015 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSU
16. propriate intervals Specifically 1 Your firm accepts incoming lots of non sterile raw materials and components based on the Certificate of Analysis CoA You do not conduct any additional testing on incoming lots of raw materials and components Also the CoA s you receive from your supplier do not include microbial testing EMPLOYEE S SIGNATURE Zada L Giles tnvestigator 9S 4 Marvin D Jones Investigator w SEE REVERSE OF THIS PAGE DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE S OF INSPECTION 404 BNA Dr Bldg 200 Ste 500 05 12 2015 05 21 2015 Nashville TN 37217 2597 ae 615 366 7801 Fax 615 366 7802 3011504027 Industry Information www fda gov oc industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A CITY STATE ZP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products 2 You have not qualified the reliability of your suppliers OBSERVATION 15 Aseptic processing areas are deficient regarding temperature and humidity controls Specifically 1 During a review of temperature and humidity logs from the past year Jan 2014 May 2015 it was found the temperature was out of range for t
17. system for monitoring environmental conditions Specifically 1 No environmental monitoring is conducted in the Lab Room where weighing and mixing take place The HVAC unit for EMPLOYEE S SIGNATURE Zada L Giles Investigator ae Marvin D Jones Investigator WPS SEE REVERSE OF THIS PAGE 05 21 2015 483 09 08 INSPECTIONAL OBSERVATIONS PAGE 3 OF 10 PAGES DEPARTMENT OF HEALTH AND HUMAN SERVICES DISTRICT ADDRESS AND PHONE NUMBER 404 BNA Dr Bldg 200 Ste 500 Nashville TN 37217 2597 615 366 7801 Fax 615 366 7802 Industry Information www fda gov oc industry FOOD AND DRUG ADMINISTRATION DATE OF INSPECTION 05 12 2015 05 21 2015 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED FEI NUMBER 3011504027 TO Vincent Matthew Poteet Owner Pharmacist FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED TN 37919 4068 Knoxville Producer of Sterile Drug Products this room is shared with other uncontrolled areas in the building and a supply vent is located directly above the space on the counter where compounding takes place Weighing and mixing processes are not performed under a hood the room is not classified and does not have HEPA filtration 2 We observed the door to the Lab Room to remain open during weighing and mixing of non sterile componen
18. tability testing Expiration dates of 2 3 months are assigned to drug products intended to be sterile that do not contain preservatives You have no data to support your product expiration dates OBSERVATION 10 Separate or defined areas to prevent contamination or mix ups are deficient regarding operations related to aseptic processing of drug products Specifically EMPLOYEE S SIGNATURE Zada L Giles Investigator Marvin D Jones Investigator MT SEE REVERSE OF THIS PAGE 05 21 2015 INSPECTIONAL OBSERVATIONS __ Es PAGE 6 OF 10 PAGES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATES OF INSPECTION 404 BNA Dr Bldg 200 Ste 500 05 12 2015 05 21 2015 Nashville TN 37217 2597 oe 3011504027 Industry Information www fda gov oc industry NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 7 TO Vincent Matthew Poteet Owner Pharmacist CITY STATE ZIP CODE COUNTRY TYPE ESTABLISHMENT INSPECTED Knoxville TN 37919 4068 Producer of Sterile Drug Products 1 Your firm s Clean Room contains two ISO 5 laminar flow hoods for aseptic filling however you only have one staging table for materials When two technicians are filling in the Clean Room they must share the table increasing the likelihood 615 366 7801 Fax 615 366 7802 FIRM NAME STREET ADDRESS The Compounding Pharmacy of America 6216 Highland Place Way Ste 101 A of a mix up
19. ts to be used to produce drug products intended to be sterile This door opens into a hallway that leads to the exit door and is adjacent to a door leading into the neighboring office 3 Your firm shares the building with an infusion office The door into their office is adjacent to the door into your Lab Room We observed employees from the infusion office coming into the Lab Room to retrieve product they have stored in your Lab Room 4 Viable air and personnel monitoring is not conducted for every production of injectable drug product Currently your firm uses settling plates for viable air and finger tip swabs for personnel monitoring only once per week and for only one technician OBSERVATION 5 Aseptic processing areas are deficient regarding air supply that is filtered through high efficiency particulate air filters under positive pressure Specifically 1 A review of your firm s Air Pressure Differential Log from the past year found the pressure from the Clean Room into the Ante Room and the Ante Room into the Lab Room to be equal in measurement This indicates there is no positive pressure to direct air supply away from the clean room 2 Air pressure is not continuously monitored in the laminar flow hoods Clean Room or Ante Room 3 There is no HEPA filtration in the Lab room where components are weighed and mixed for producing drug products intended to be sterile Weighing and mixing does not take place
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