Inspection Details
The United States Food and Drug Administration (USFDA) conducted an inspection at the Company's API manufacturing facility located at Jaggaiahpet, Andhra Pradesh, India. The facility identification number is FEI No. 3005554260. The inspection period was from 14 September 2026 to 19 September 2026.
Inspection Outcome
The inspection concluded with the issuance of a Form FDA 483 containing five observations. The Form FDA 483 is a document issued by FDA investigators to management at the conclusion of an inspection when investigators have observed any conditions that may constitute violations of the Food Drug and Cosmetic Act.
Company Response
The Company has initiated appropriate corrective and preventive actions (CAPA) in response to the observations. The Company will submit its formal response to the USFDA within the stipulated timeline. The Company reaffirmed its commitment to quality and regulatory compliance.