Date:
May 27, 2026
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 following an inspection of BPI Labs, LLC, an outsourcing facility located in Largo, Florida. The document highlights observations made by FDA investigators during their review of the facility in April 2026.
The inspection of the BPI Labs facility (FEI: 3015156709) concluded on April 17, 2026. As a registered outsourcing facility, the company is required to adhere to rigorous Current Good Manufacturing Practice (CGMP) standards to ensure the safety and quality of the compounded medications they produce for the healthcare industry.
A Form 483 is issued when investigators identify conditions that may represent violations of federal safety and quality regulations. These observations are intended to provide the firm with notice of potential issues that require assessment and corrective action to maintain regulatory compliance.
The release of this document via the FDA’s OII FOIA Electronic Reading Room is part of the agency’s effort to maintain transparency regarding the manufacturing standards of drug production facilities. Stakeholders are encouraged to review the inspection findings to stay informed on facility compliance status.
Source: FDA Electronic Reading Room
Link:
http://www.fda.gov/about-fda/fda-commissioner/bpi-labs-llc-largo-fl-483-issued-4172026
Keywords:
FDA, Form 483, BPI Labs LLC, Largo Florida, Outsourcing Facility, Drug Safety, CGMP, Inspection Report