USFDA Issues Form 483 to Natco Pharma: Seven Observations Noted

Natco Pharma received a Form 483 with seven observations from the USFDA after an inspection in Hyderabad. Conducted from June 9-19, 2025, the inspection pointed out conditions potentially violating the FD&C Act. Natco is committed to addressing these within the deadline while ensuring cGMP compliance.

The US Food and Drug Administration (USFDA) has issued a Form 483 with seven observations to Natco Pharma's Hyderabad division, the company announced on Thursday. This notice follows an inspection conducted at Natco's pharma division in Kothur, Hyderabad, between June 9 and June 19, 2025.

The Form 483 is an official document that highlights potential violations noticed by investigators, correlating with the Food Drug and Cosmetic Act and related legislation. Despite these observations, Natco Pharma expressed confidence in addressing them promptly and maintaining its commitment to high-quality pharmaceutical production.

Natco assured stakeholders of its dedicated efforts to comply with current Good Manufacturing Practices (cGMP) and continue supplying top-tier products to its international client base.

(With inputs from agencies.)