Laboratory Controls

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): Established sampling plans and test procedures are not followed

Procedures 0317-SOP-QC-00193 “Sampling and Testing procedure of *** and 0317-SOP- C-00118 “Quality monitoring of *** System” were not followed for

30/04/2024

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

Your QC Microbiology laboratory has no equipment usage logbook or any other document that records incubator usage details for a

19/04/2024

Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, test procedures

The Microbial Limit Testing performed on *** Tablets Batch *** on long term stability conditions at time point 35 months

09/04/2024

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

The hold time study performed under Protocol Cum Report to Generate Microbial Enumeration Test Data of *** Tablets ***mg B/P/G/22/102

09/04/2024

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

LOT/AR Numbers *** and *** show *** samples were collected on 29-Jan-24 for micro testing at 08:14, 08:20, and 08:04,

06/04/2024

Microbiology FDA 483 (Eugia SEZ): Procedures not followed for Enumeration of Microbial Colonies

Your firm failed to follow SOP HO-CQA-SOP-072, Enumeration of Microbial Colonies. On February 19 2024, while reviewing the personnel monitoring

21/03/2024

Microbiology FDA 483 (Panacea Biotec): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications & standards

Your firm does not perform supplemental destructive testing to ensure the products are essentially free of visible particulates for ***

11/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Appropriate controls are not established for Computer System

On Jul 26, 2023, observed a Microbiology technician use another technician’s sign in for the *** Particulate Matter system to

03/03/2024

Microbiology FDA 483 (Central Admixture Pharmacy): Results of stability testing are not used in determining appropriate storage conditions and expiration dates

Your *** stability program does not include sterility or endotoxin testing at the endpoint. Your firm only tests sterility and

01/03/2024

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

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

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

Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, test procedures

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 (Eugia SEZ): Procedures not followed for Enumeration of Microbial Colonies

Microbiology FDA 483 (Panacea Biotec): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications & standards

Microbiology FDA 483 (Central Admixture Pharmacy): Appropriate controls are not established for Computer System

Microbiology FDA 483 (Central Admixture Pharmacy): Results of stability testing are not used in determining appropriate storage conditions and expiration dates

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

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