USFDA Issues Three Observations to Gland Pharma's Visakhapatnam Facility

26 Feb 2025 , 12:22 PM

On February 25, Gland Pharma Ltd said that the USFDA has made a key inspection of its Andhra Pradesh facility. The inspection took place at the company’s sterile API manufacturing unit in Visakhapatnam, located in Jawaharlal Nehru Pharma City (JNPC).

The FDA conducted the pre-approval inspection (PAI) from Feb. 19, 2025, to Feb. 25, 2025, as part of the regulatory process for sterile APIs. The USFDA issued three Form 483 observations to Gland Pharma after the inspection was over.

The company added that the observations were procedural and unrelated to an issue with data integrity. Moreover, Gland Pharma wrote that the observations weren’t repetitive from any past inspection. It has also assured the USFDA to file the corrective and preventive action plan within the time frame.

At the time of writing at 12:20 pm on February 26, 2025, Shares of Gland Pharma Ltd is currently trading at ₹1577 which is a 3.39% gain than the previous close. The stock has witnessed a total of 13% dip in the last one year and 9.50% gain in the last one month.

Understanding Pre-Approval Inspection (PAI):

In the US, the Food Drug and Cosmetic Act (FDCA) gives the FDA the authority to review and approve New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). Pre-approval Inspection (PAI) helps in ensuring that the manufacturing, processing, packaging, and testing facilities meet the regulatory requirements before the approval is granted.

What is Form 483?

Form 483 is issued by the USFDA post an inspection containing the observations on compliance gaps at the facility. The observations point to areas where the company must take corrective action but they are not a final regulatory decision. After the issuance of a Form 483, the company is allowed to submit a formal response within 15 days explaining how these issues will be resolved.