Suppliers / BPI Labs

BPI Labs

United States 88 employees Updated 9 July 2026

BPI Labs is a finished-dose manufacturer based in United States. It appears in 16 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 23 April 2025 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 2 with an FDA FEI number
16
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 23 April 2025 VAI US FDA
  • 21 February 2025 NAI US FDA
  • 10 March 2022 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Evanston, United States 3008875046
Largo, United States 3015156709

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 16 1

Questions about BPI Labs

Does BPI Labs hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for BPI Labs. It does have 16 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is BPI Labs FDA-registered?
2 sites operated by BPI Labs carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did BPI Labs's last inspection go?
The most recent inspection on record closed on 23 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does BPI Labs manufacture?
2 registered sites are on record, in United States (Evanston and Largo). Every site is listed on this page with the register it came from.
Which regulators recognise BPI Labs's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 8 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 23 April 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates