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# BPI Labs Cited After FDA Inspection
- URL: https://www.fdaweb.com/bpi-labs-cited-after-fda-inspection/
- Published: 2026-05-29T12:00:00.000Z
- Updated: 2026-09-14T13:40:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161226

FDA has cited BPI Labs for potential cross-contamination risks at its outsourcing facility in Largo, FL, according to an inspection report issued following an April inspection. Agency investigators inspected the facility from 4/6-17 and documented concerns involving cleaning verification procedures used on manufacturing equipment.

According to the [inspection report](https://www.fda.gov/media/192439/download?ref=fdaweb.com), the agency found that the company did not collect and analyze swab samples to verify removal of testosterone residues before a production line was released for manufacturing tirzepatide and pyridoxine hydrochloride injections.

FDA investigators also wrote that without analytical verification of cleaning effectiveness, there was no assurance that testosterone residues had been adequately removed to prevent contamination of subsequent batches.