No Procedure followed

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 : Procedures applicable to the quality unit are not in writing and fully followed

When counting microbial plates for colonies (CFU/mL) in your Microbiological Lab, a calculation is performed to determine the CFU/ml results

29/01/2024

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 : Procedures applicable to the quality unit are not in writing and fully followed

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination sterile drug product are not established and followed

Microbiology FDA 483 (Zydus Lifesciences): Appropriate controls are not exercised over computers or related systems

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

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

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

Microbiology FDA 483 (Zydus Lifesciences): Established sampling plans and test procedures are not followed

Microbiology FDA 483 (Precision Equine LLC): Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination

Microbiology FDA 483 (Precision Equine LLC): Procedures to prevent microbiological contamination are not established; written and followed

Microbiology FDA 483 (Precision Equine LLC): No written testing program designed to assess the stability characteristics of drug products

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