FDA 483 - Windlas Healthcare Private Limited - August 30, 2019

Windlas Healthcare Private Limited, a drug product manufacturer in Dehradun, India, was cited for severe deficiencies across its Quality Unit, laboratory operations, and document control during an FDA inspection. The firm failed to adequately investigate unknown peaks and OOS results, lacked oversight on electronic data and controlled documents, and was observed attempting to conceal or destroy records during the inspection. These issues indicate a systemic breakdown in ensuring product quality and data integrity.