FDA 483 - Caraco Pharmaceutical Laboratories, Ltd. - January 11, 2013

During an inspection from January 7-11, 2013, the FDA issued a Form 483 to Caraco Pharmaceutical Laboratories, Ltd., citing significant deviations from manufacturing standards. The observations highlighted critical failures in maintaining quality control and ensuring product integrity.One primary concern was the improper storage of drug products. The company failed to perform temperature mapping for material storage rooms in production areas, where raw materials and finished drug products like Lactose Monohydrate and Carvedilol Tablets were kept. This raised questions about whether products were stored under conditions appropriate to maintain their identity, strength, quality, and purity.Furthermore, the inspection revealed the quality control unit did not consistently follow its own procedures. The firm's Corrective and Preventative Action (CAPA) program suffered from delayed interim reporting, with multiple CAPAs not meeting the specified two-month minimum reporting requirement. Additionally, cleaning validation procedures were not followed, as a new product, Ticlopidine Hydrochloride Tablets, was processed on shared coating equipment before its formal assessment into the cleaning validation matrix was finalized. Lastly, mapping for a finished product outgoing storage space had not been conducted during winter months, despite protocol requirements, leading to drug products with specific storage requirements being held in unmapped areas.These observations indicate a need for Caraco Pharmaceutical Laboratories to implement robust corrective actions, including completing all required temperature mappings, strictly adhering to CAPA reporting timelines, ensuring cleaning validation assessments precede manufacturing, and completing environmental qualifications for all storage areas to comply with Good Manufacturing Practices.