Aseptic Technique

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

Requalification of the *** Sterilization Process for *** Loads *** Bottle Formats) in the *** Model ***, Equipment ID# E-0832-W,

03/04/2024

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

Surface sampling locations within the ISO-5 areas for processing human and animal drug are not supported with appropriate studies.

03/04/2024

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

Investigations are not always performed for environmental / personnel monitoring excursions within the ISO-5 and ISO-7 (action limits of ***

03/04/2024

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

Specifically, disinfectant efficacy studies have not been performed for the ***, and the *** cleaning solutions used within your IS0-5

02/04/2024

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

Specifically, your firm has no written procedures on what corrective actions are to be performed when aseptic areas have a

31/03/2024

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

On 07/10/2023 and 07/12/2023, inspected the post assembly and/ or aseptic filling of *** mL batch *** respectively. Observed the

30/03/2024

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

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.): 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

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