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FDA establishment 3015156709, Largo, Florida, United States. Part of BPI Labs's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Apr 23, 2025
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02018Inspections0
020192019Inspections0vs 2018+0
02020Inspections0vs 2019+0
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
02024Inspections0vs 2023+0
220252025Inspections2vs 2024+2
02026Inspections0vs 2025−2
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
FDCA 505-1(f)(3)(A): Failure to comply with REMS Elements to Assure Safe Use (ETASU) A1
FDCA 503B(a)(10)(A): Drug product labels, fails to include1
Inspections
2 inspections, newest first
Apr 23, 2025
Drugs · Bioresearch Monitoring
1 cited reference
FDCA 505-1(f)(3)(A). Failure to comply with REMS Elements to Assure Safe Use (ETASU) A An application holder did not ensure mechanisms are in place that allow healthcare providers (HCPs) the ability to complete the certification process, as required by your approved REMS Element to Assure Safe Use (ETASU) A.
Voluntary Action Indicated (VAI)
Feb 21, 2025
Drugs · Drug Quality Assurance
1 cited reference
FDCA 503B(a)(10)(A). Drug product labels, fails to include The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Largo, Florida, United States. Part of