FDA 483 - Shilpa Medicare Limited - February 13, 2020

This FDA Form 483 report details significant deficiencies at Shilpa Medicare Limited, highlighting a systemic failure of the Quality Unit to ensure cGMP compliance for sterile and non-sterile drug products. Key issues include inadequate investigation of complaints and out-of-specification results, unvalidated manufacturing processes, and critical shortcomings in laboratory controls, environmental monitoring, and instrument calibration. The observations collectively indicate a lack of robust quality oversight impacting product identity, strength, quality, and purity.