Indian manufacturing plants manufacturing for the United States should comply with the regulations of USFDA,
Indian Pharmaceutical Industries are the major suppliers of generic drugs to the US Market. USFDA has the right to inspect
manufacturing plants periodically to ensure manufacturing site compliance with the regulations. USFDA inspectors may issue
form483 about their findings and unjustified observations may turn into Warning letters. Investigation failures and Insufficient
corrective actions to Customer complaints, OOS and Deviations are grabbing more attention from USFDA auditors during
their manufacturing site inspection and these observations were turning into form 483 and Warning letters for Indian
Pharmaceutical Industries. A cross-sectional analysis was performed for the warning letters issued from 2010 to 2021 and all
Warning letters issued from Indian Pharmaceutical Industries during the study period and the Data has collected from UDFDA
publically accessible database. About 114 USFDA issued Indian Pharmaceutical industries warning letters 211 CFR citations
& 595 observations were analysed and categorised based on the violation theme. Insufficient Corrective actions of Out of
specifications, Consumer / Market complaint and deviation marks the primary reason for the issue of warning letters under
cGMP non-compliance violation.
Key words: CAPA, Deviation, Out of Specification, Customer Complaint, USFDA.
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