FDA 483 - Goran Pharma Private Ltd - February 28, 2025

Goran Pharma Private Limited, a manufacturer in Dist. Sihor, Gujarat, India, was inspected by the FDA. The inspection revealed significant deficiencies in record-keeping practices, including the lack of documented procedures for electronic visual inspection records and proper controls for digital copies. Additionally, the firm failed to establish procedures to prevent objectionable microorganisms in non-sterile drug products and lacked proper documentation of initials or signatures in laboratory records.