Gland Pharma Facility Under USFDA Scrutiny: Three Procedural Observations Noted

Gland Pharma Ltd received a Form 483 from the USFDA with three procedural observations after a facility inspection in Visakhapatnam. These are not repeated or data integrity-related issues. Corrective measures will be provided to the USFDA within the required timeframe.

The US Food and Drug Administration (USFDA) has issued a Form 483 to Gland Pharma Ltd's facility at JNPC, Visakhapatnam, following a pre-approval inspection of sterile APIs conducted between February 19 and February 25, 2025.

This latest inspection resulted in three procedural observations, which were highlighted but noted not to be repeated or connected to data integrity concerns, according to the company's regulatory filing.

Gland Pharma intends to address these observations by submitting corrective and preventive actions to the USFDA within the designated timeline, ensuring compliance with the regulatory standards.