FDA 483 - Chemeca Drugs Private Limited - March 10, 2021

Chemeca Drugs Private Limited, an API manufacturer in Visakhapatnam, India, was cited for significant deficiencies in its quality unit procedures, laboratory investigations, and equipment cleaning and storage practices. Observations included inadequate retesting protocols, failure to investigate system suitability failures, insufficient cleaning validation, and contaminated production equipment. These issues indicate a lack of robust quality control and manufacturing process oversight.