Manufacturing control

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): Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations

Your firm’s containment control and monitoring programs are inadequate to address the possibility of cross contamination of *** pharmaceutical products

22/05/2024

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

Review of the non-viable particle count (NVPC) continuous monitoring from the ***, which is used to transport *** vials from

30/04/2024

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 (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 (Panacea Biotec): Equipment used is not of appropriate design and suitably located

Specifically, inside the aseptic area used in the manufacture of *** Injection, ***mg/vial, a box (approximately ****), is outlined on

11/03/2024

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

Specifically, Quality oversight is inadequate in that the aseptic processing areas are not designed to permit viewing through windows to

11/03/2024

Microbiology FDA 483 : Procedures to prevent microbiological contamination of sterile drug products are not established

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established

09/02/2024

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): Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations

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

Microbiology FDA 483 (Panacea Biotec): Equipment used is not of appropriate design and suitably located

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

Microbiology FDA 483 : Procedures to prevent microbiological contamination of sterile drug products are not established

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