FDA 483 - Sri Krishna Pharmaceuticals Limited - May 19, 2023

During an inspection conducted from May 15-19, 2023, the FDA identified significant observations at Sri Krishna Pharmaceuticals Ltd. - Unit II, a drug manufacturer in Hyderabad, India. The inspection revealed multiple instances of non-compliance with current Good Manufacturing Practice (cGMP) regulations.

Key issues included a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results, particularly concerning impurity levels in drug products, leading to product recalls without timely FDA notification. The company demonstrated inadequate process validation protocols, with manufacturing continuing despite failed validation batches and a lack of proper root cause analysis. Data integrity concerns were prevalent, including allegations of result manipulation, backdating of documents, and a lack of control over analytical records and forms.

Further observations highlighted insufficient equipment cleaning, poor facility maintenance, and a deficient document control system. The Quality Unit's oversight was found lacking, especially regarding electronic laboratory systems and complaint handling, where investigations were delayed, inadequately classified, and failed to follow established procedures.

To address these observations, Sri Krishna Pharmaceuticals Ltd. is required to implement comprehensive corrective and preventive actions to ensure compliance with cGMP, restore data integrity, enhance quality oversight, and establish robust systems for investigations, process validation, and complaint management.