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.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

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

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Open risk flags

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

Sources on this page

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