Clean Room Practices

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 (Aurobindo/Eugia Pharma) : Procedures not established & followed to prevent microbiological contamination of sterile drug products

During aseptic filling operations, procedure HO-CQA-SOP-2*** “Clean Room Practices and Aseptic Behavior” and line specific intervention procedures were not followed:

15/02/2024

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 (Aurobindo/Eugia Pharma) : Procedures not established & followed to prevent microbiological contamination of sterile drug products

Microbiology FDA 483 (Alkem Laboratories): Responsibilities and procedures applicable to the quality control unit are not in writing and fully

Microbiology FDA 483 (Jubilant Generics): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Microbiology FDA 483 (Contract Pharmaceuticals): Failure to thoroughly review any unexplained discrepancy

Microbiology FDA 483 (Wedgewood Connect): Procedures to prevent microbiological contamination of drug products purporting to be sterile are not established and followed

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

Microbiology FDA 483 (Wedgewood Connect): Written records are not always made of investigations into unexplained discrepancies

Microbiology FDA 483 (Wedgewood Connect): Aseptic areas are deficient for cleaning and disinfecting the room and equipment to produce aseptic conditions

Microbiology FDA 483 (Biocon Sdn.): Fails to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods

Microbiology FDA 483 (Biocon Sdn.): Failure to have written procedures for connective and preventative actions during loss or reversals of different pressure in classified aseptic areas

Microbiology FDA 483 (Biocon Sdn.): Procedures to prevent microbiological contamination are not established, written, or followed