What happened
Dr. Reddy’s Laboratories stated that the U.S. Food and Drug Administration (U.S. FDA) issued three observations after inspecting Dr. Reddy’s Laboratories’ Srikakulam, Andhra Pradesh facility. The inspections included a Pre-Approval Inspection (PAI) and a Good Manufacturing Practices (GMP) check for the FTO-SEZ Process Unit-02.
Dr. Reddy’s Laboratories reported that the U.S. FDA conducted the inspections from July 20 to July 29. Dr. Reddy’s Laboratories reported receiving a Form 483 listing the observations and stated it will address the observations within the stipulated timeline.
Background and earlier position
Pharmaceutical regulators commonly evaluate whether a manufacturing site follows Good Manufacturing Practices (GMP)—documented procedures and controls used to help ensure consistent drug quality.
A Pre-Approval Inspection (PAI) is an inspection intended to verify that a manufacturing facility and processes can meet regulatory expectations relevant to product approval.