FDA 483 - Intas Pharmaceuticals Limited - February 17, 2017

Intas Pharmaceuticals Limited, an API and drug product manufacturer in Ahmedabad, India, was cited for significant deficiencies during an FDA inspection. Observations included a lack of established written procedures for equipment cleaning and storage, as well as inadequate studies for pre-cleaning and hold times. Additionally, the firm failed to store Active Pharmaceutical Ingredients (API) under recommended temperature conditions, potentially compromising product quality.