The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) for Sterile APIs at Gland Pharma’s facility at JNPC, Visakhapatnam between February 19 and February 25.
The inspection was concluded with three Form 483 Observations, which are procedural in nature. The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period,’‘ the Hyderabad-based company informed BSE on Tuesday.
The observations issued were neither repeated observations nor related to data integrity, the company added.
