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BPI Labs LLC FDA Inspection Record

FEI 3015156709 · Inspections, Form 483s, warning letters and import refusals

BPI Labs LLC is an FDA-registered facility (FEI 3015156709) located in Largo, FL, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Mar 20, 2025
Form 483 and inspection documents
3 in FDA's reading room

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 23, 2025Voluntary Action Indicated (VAI)Failure to comply with REMS Elements to Assure Safe Use (ETASU) A (FDCA 505-1(f)(3)(A))
Feb 21, 2025No Action Indicated (NAI)Drug product labels, fails to include (FDCA 503B(a)(10)(A))

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Apr 6, 2026 to Apr 17, 2026, issued Apr 17, 2026 (dates printed on the document). FDA listing date Apr 17, 2026. Published by FDA May 27, 2026.
  • 483 on FDA.gov
    Inspection Feb 10, 2025 to Feb 21, 2025, issued Feb 21, 2025 (dates printed on the document). FDA listing date Feb 21, 2025. Published by FDA Feb 28, 2025.
  • 483 on FDA.gov
    Inspection Apr 19, 2021 to Apr 30, 2021 (dates printed on the document). FDA listing date Apr 30, 2021. Published by FDA May 31, 2022.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
BPI Labs, LLC
Location
Largo, FL (US)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE
Source
decrs

Compliance actions

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.