FDA 483 - Sri Krishna Pharmaceuticals Limited - Unit IV - August 04, 2023

The FDA issued a Form 483 to Sri Krishna Pharmaceutical LTD, an API manufacturer located in Telangana, India, following an inspection conducted prior to August 4, 2023. The document details several critical observations regarding the company's quality systems and adherence to good manufacturing practices. Main violations include inadequate investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results, often concluding without assignable cause or sufficient scope. Instances of data falsification were noted, specifically regarding temperature records during power outages, which led to the release of impacted batches. The inspection also identified significant deficiencies in laboratory controls, such as unvalidated test methods, inadequate system suitability for chromatographic purity, unchecked manual data integration practices, and a lack of audit trails on Quality Control equipment. Furthermore, equipment used in manufacturing lacked suitable design for its intended use, with critical process parameters relying on manual control without supporting data. Documentation for Corrective and Preventive Action (CAPA) effectiveness checks was insufficient, and cleaning procedures and validations were found lacking in detail and scientific basis to prevent contamination. Finally, the stability monitoring program was deemed deficient, with test procedures not proven to be stability-indicating. Sri Krishna Pharmaceutical LTD is required to respond to these observations with a comprehensive plan for corrective and preventive actions to ensure compliance and product quality.