FDA 483 - Nifty Labs Pvt Ltd - September 25, 2025

An FDA inspection conducted at Nifty Labs Private Limited in Kondapally, India, on or around September 25, 2025, identified two significant observations detailed in an FDA Form 483. The inspection focused on the firm's role as an intermediate manufacturer for products destined for the U.S. market.

The first observation concerned inadequate maintenance of the company's production buildings and facilities. Inspectors noted condensation actively dripping from air conditioning ducts onto raw materials, creating a potential contamination hazard. Furthermore, the facility exhibited widespread water stains and mold-like substances on ceilings and walls, along with rust on pipes and valves, indicating deficiencies in facility upkeep.

The second observation highlighted issues with data integrity within the laboratory. Specifically, the High-Performance Liquid Chromatography (HPLC) system used for testing intermediates permitted "project administrators" (reviewers) to access and perform critical analyst functions, such as aborting and editing test sequences, without proper justification. This unsegregated access compromises the completeness and reliability of laboratory data crucial for ensuring product quality and adherence to established specifications. Nifty Labs Private Limited is required to address these observations promptly by implementing comprehensive corrective and preventive actions to ensure compliance with quality standards.