Crown Laboratories
United States Updated 9 July 2026
Crown Laboratories is a finished-dose manufacturer based in United States. It appears in 11 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, SAHPRA (ZA) and Health Canada. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 19 September 2025 as VAI.
1
registered plants
1 with an FDA FEI number
11
filings
across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 19 September 2025 VAI US FDA
- 15 March 2018 NAI US FDA
- 15 February 2018 NAI US FDA
- 8 April 2016 VAI US FDA
- 24 September 2014 OAI US FDA
- 14 February 2014 VAI US FDA
- 9 March 2012 VAI US FDA
- 3 November 2011 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Johnson City, United States | 1019820 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 4 | 1 |
| SAHPRA (ZA) | 4 | None |
| Health Canada | 3 | None |
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Open risk flags
- The most recent inspection outcome was VAI, on 19 September 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates