FDA 483 - Zen Chemicals Private Limited - March 28, 2023

Zen Chemicals Pvt. Ltd., a critical API intermediate manufacturer in Dombivili, India, received a Form 483 citing significant deficiencies during an FDA inspection. Observations included inadequate equipment cleaning and sanitization, a failure to investigate multiple analytical sample reruns, and insufficient controls over computerized laboratory systems. Additionally, the firm neglected to perform equipment qualification and ensure proper employee training in cleaning procedures, indicating systemic quality control issues.