Bespak Hc is a finished-dose manufacturer based in United Kingdom. It appears in 3 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with INVIMA (CO), ARCSA (EC) and EDE (AE). Its GMP standing is certified by MHRA (UK), MFDS (Korea) and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 26 November 2020 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Holmes Chapel, United Arab Emirates | Not on file |
| CREWE, United Kingdom | Not on file |
| United Kingdom, United Kingdom | 3001621739 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| INVIMA (CO) | 1 | None |
| ARCSA (EC) | 1 | None |
| EDE (AE) | 1 | None |
| MHRA (UK) | None | 4 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| NCELS (KZ) | None | 1 |
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