Validation

Microbiology FDA 483 (Eagl e Pharma Outsourcing LLC): Microbiological Contamination Prevention Issues

Your container closure integrity test for *** Injection (USP) ***mg/***ml is inadequate, The test used empty vials instead of fille

20/04/2025

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

Your container closure integrity test for *** Injection (USP) ***mg/***ml is inadequate, The test used empty vials instead of fille

30/06/2024

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

Product contact equipment including *** stopper drums, *** were sterilized without outer wrapping and transferred from Grade A cart to

30/06/2024

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

In commercial production, sterile *** API is aseptically filled into canisters, approximately *** batch. *** filling, *** canister is opened

15/05/2024

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

The MODA software system is used for microbiology documentation of sampling and testing for the *** system *** and environmental

01/05/2024

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

Procedure 0317-SOP-MFG-00039 “Clean room and aseptic behavior” was not followed to ensure sterilized components are only contacted with sterile forceps

30/04/2024

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

The airflow visualization study conducted on Line *** Protocol Document CHL-QUA-00315-00, effective June 05, 2021, under dynamic conditions did not

30/04/2024

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

Your environmental monitoring (EM) of the ISO 5 Laminar Airflow Hood (LAFH) in Sterile Non-Hazardous Drug Suite and the ISO

26/04/2024

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

on 4/3/24 1 observed the manual visual inspection process of *** USP ***% batch *** for approximately *** during this

18/04/2024

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

Calibration certificates issued on Monday April 1 2024 of *** ES-PR-*** (location filling zone ***) and ES-PR-*** (location filling zone

18/04/2024

Microbiology FDA 483 (Eagl e Pharma Outsourcing LLC): Microbiological Contamination Prevention Issues

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

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

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

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

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 (Eagl e Pharma Outsourcing LLC): Microbiological Contamination Prevention Issues

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

Microbiology FDA 483 (Jubilant Radiopharmacies): The movement of first air in the ISO 5 area is blocked or disrupted

Microbiology FDA 483 (Jubilant Radiopharmacies): Personnel were observed performing aseptic processing outside of an ISO 5 area

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations

Microbiology FDA 483 (Eugia Pharma Specialities): There is a failure to thoroughly review any unexplained discrepancy and 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

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