Aseptic Behavior

Microbiology FDA 483 (Front Door Pharmacy): Blocked the movement of first pass air by personnel conducting aseptic manipulations

Specifically, during the visual sterile production observation of the finished sterile drug product, P105 (PAP30MG/ PHE1MG/ PGE10MCG), Lot # 051321@***,

25/03/2024

Microbiology FDA 483 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

The designs of Vial Line *** systems ( ***), Vial Line *** (System ***), Flexible Fill Line *** (System ***),

23/03/2024

Microbiology FDA 483 (Eugia SEZ): Procedures designed to prevent microbiological contamination are not followed

Your firm failed to follow EP4-PR-SOP-042, “Guidelines for Working in Aseptic Area” and EP4-MB-SOP-028, “Viable Monitoring Program”. The following are

21/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Procedures are not established, written and followed to prevent microbiological contamination

Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:

On July 11, 2023, two (2) of

29/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Procedures are not established, written and followed to prevent microbiological contamination

Specifically, during setup, aseptic filling, transfer of equipment and components, and line disassembly/cleaning in the Grade A area of ***

23/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Personnel infrequently changed and sanitized gloves to prevent contamination

n 10/23/2023, during observation of your firm’s automated vial filling operation within your firm’s ISO 5 Cleanroom, for the drug

19/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Aseptic manipulations where the movement of first air in the ISO 5 area is blocked or disrupted

Specifically, on 11/13/2023, during a review of selected *** aseptically sterile lots that were produced within your firm’s Formulation Room

19/02/2024

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : No adequate validation of the aseptic process to prevent microbiological contamination

(1) Block *** Line *** re-qualification and *** exposure were not adequately performed:

(a) During *** re-qualification, Chemical Indicators (CI)

17/02/2024

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : Batch production and control records do not include complete information

(1) Production personnel used the “Check List for Verification of Product Contact Parts for Line *** to document the ***

16/02/2024

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : Laboratory records do not include complete data (data integrity issues)

(1) The Line *** contains a total of *** and integrity testing of all *** is perfo1med after *** batch.

16/02/2024

Microbiology FDA 483 (Front Door Pharmacy): Blocked the movement of first pass air by personnel conducting aseptic manipulations

Microbiology FDA 483 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Eugia SEZ): Procedures designed to prevent microbiological contamination are not followed

Microbiology FDA 483 (Central Admixture Pharmacy): Procedures are not established, written and followed to prevent microbiological contamination

Microbiology FDA 483 (Kilitch Healthcare): Procedures are not established, written and followed to prevent microbiological contamination

Microbiology FDA 483 (Empower Clinic Services) : Personnel infrequently changed and sanitized gloves to prevent contamination

Microbiology FDA 483 (Empower Clinic Services) : Aseptic manipulations where the movement of first air in the ISO 5 area is blocked or disrupted

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : No adequate validation of the aseptic process to prevent microbiological contamination

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : Batch production and control records do not include complete information

Microbiology FDA 483 (Aurobindo/Eugia Pharma) : Laboratory records do not include complete data (data integrity issues)

Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Eugia Steriles): Control procedures are not established which validate the performance of those manufacturing processes

Microbiology FDA 483 (Eugia Steriles): Input to and output from the computer and records or data are not checked for accuracy

Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed

Microbiology FDA 483 (Zydus Lifesciences): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination

Microbiology FDA 483 (Zydus Lifesciences): Buildings used in the manufacturing of a drug product are not maintained in a good state of repair

Microbiology FDA 483 (Zydus Lifesciences): Procedures designed to prevent microbiological contamination are not written and followed

Microbiology FDA 483 (Zydus Lifesciences): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Cipla Limited): Failure to clean and maintain equipment and utensils to prevent contamination

Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, test procedures