Dr. Reddy’s Laboratories has received a United States Food and Drug Administration (USFDA) Form 483 with two observations following a Pre-Approval Inspection (PAI) at its FTO-11 manufacturing facility. The inspection by the U.S. health regulator concluded on October 7, 2026.

The USFDA issued the form following a Pre-Approval Inspection (PAI) conducted at the facility from October 5 to October 7, 2026. A PAI is standard protocol to evaluate whether a facility meets Good Manufacturing Practice (GMP) standards before approving pending drug applications.

The company stated it will address the observations comprehensively within the stipulated timeline.