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
The MODA software system is used for microbiology documentation of sampling and testing for the *** system *** and environmental
Procedures 0317-SOP-QC-00193 “Sampling and Testing procedure of *** and 0317-SOP- C-00118 “Quality monitoring of *** System” were not followed for
Your QC Microbiology laboratory has no equipment usage logbook or any other document that records incubator usage details for a
The Microbial Limit Testing performed on *** Tablets Batch *** on long term stability conditions at time point 35 months
The hold time study performed under Protocol Cum Report to Generate Microbial Enumeration Test Data of *** Tablets ***mg B/P/G/22/102
LOT/AR Numbers *** and *** show *** samples were collected on 29-Jan-24 for micro testing at 08:14, 08:20, and 08:04,
Specifically, your firm was notified a highly pathogenic microorganism was recovered during environmental monitoring of the production area and an
Your firm failed to follow SOP HO-CQA-SOP-072, Enumeration of Microbial Colonies. On February 19 2024, while reviewing the personnel monitoring
Your firm does not perform supplemental destructive testing to ensure the products are essentially free of visible particulates for ***
Specifically, accuracy, sensitivity, specificity, and reproducibility of TAMC (Toral Aerobic Microbial Count) test used to routinely test *** for the