FDA 483 - BPI Labs LLC - April 17, 2026

Between April 6 and April 17, 2026, the FDA inspected BPI Labs, LLC, an outsourcing facility located in Largo, Florida. The inspection resulted in several significant observations regarding the facility"s compliance with the Food, Drug, and Cosmetic (FD&C) Act, particularly Section 503B. A primary violation involved the company compounding drug products using bulk substances, such as Tirzepatide, that are not permitted because they do not appear on the FDA’s approved list for clinical need or drug shortages. Additionally, the Quality Control unit failed to ensure sterile manufacturing safety. Specifically, "media fill" simulations did not represent worst-case production conditions, and visual inspection processes for detecting contaminants were insufficient, leading to the release of batches without adequate verification of purity. The facility also lacked proper reviews of environmental monitoring data during production. Further concerns were raised regarding the facility"s stability testing, which failed to adequately monitor impurities in certain ingredients. Finally, the FDA noted a lack of cleaning verification; the firm did not perform analytical swabbing to confirm the removal of residues like Testosterone between batches, creating a risk of cross-contamination. Under the regulatory framework of the FD&C Act, these findings suggest the facility’s products may have been prepared under insanitary conditions. BPI Labs is required to respond to these observations by outlining corrective actions or providing justifications to the FDA to ensure future compliance.