FDA 483 - Zenara Pharma Pvt Ltd - December 16, 2019

Zenara Pharma Pvt Ltd in Hyderabad, India, was issued a Form 483 with nine observations following an FDA inspection. The firm demonstrated significant deficiencies across its quality control unit, laboratory procedures, production records, equipment maintenance, and personnel training. Key issues include inadequate investigations into out-of-specification results, insufficient process controls for scale-up batches, and incomplete master production records, indicating a lack of adherence to current Good Manufacturing Practices.