Suppliers / Bostal

Bostal

United States Updated 9 July 2026

Bostal is a finished-dose manufacturer based in United States. It appears in 18 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 4 December 2024 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
18
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 4 December 2024 VAI US FDA
  • 5 April 2023 VAI US FDA
  • 5 January 2018 VAI US FDA
  • 25 May 2016 VAI US FDA
  • 18 December 2013 VAI US FDA
  • 5 June 2012 VAI US FDA
  • 3 June 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Edison, United States 3008953516

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 18 1

Questions about Bostal

Does Bostal hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Bostal. It does have 18 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Bostal FDA-registered?
One site operated by Bostal carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Bostal's last inspection go?
The most recent inspection on record closed on 4 December 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Bostal manufacture?
1 registered site is on record, in United States (Edison). Every site is listed on this page with the register it came from.
Which regulators recognise Bostal'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

  • The most recent inspection outcome was VAI, on 4 December 2024.

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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