Primary documents underlying my reporting and writing. Where a piece rests on a record I obtained directly, the record is posted here in full so readers can check the claim against the source.
Inspection of a contract testing laboratory in Bengaluru, India, conducted February 4–6, 2026. Investigators recorded three observations covering microbiological data integrity, out-of-specification investigations and CAPA adequacy, and quality control unit procedures. Obtained through a Freedom of Information Act request.
A Form 483 lists observations made by FDA investigators during an inspection. It is not a final agency determination regarding compliance, and a firm may respond to, contest, or have already addressed any observation it contains. Redactions in these documents were applied by the agency prior to release.