Abbott Laboratories is a finished-dose manufacturer based in Germany. It appears in 245 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, SFDA (Saudi Arabia) and EDA (EG). Its GMP standing is certified by ZLG (DE), EMA and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 30 May 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Neustadt, United Arab Emirates | Not on file |
| NEUSTADT AN DER WEINSTRASSE, Germany | Not on file |
| Hannover, Germany | Not on file |
| Lower Saxony, Germany | Not on file |
| Germany, Germany | 3002808216 |
| Neustadt, Germany | Not on file |
1 further sites are on record.
| Regulator | Filings | GMP certificates |
|---|---|---|
| Health Canada | 136 | None |
| SFDA (Saudi Arabia) | 32 | None |
| EDA (EG) | 20 | None |
| RAMA (GE) | 15 | None |
| DAV (Vietnam) | 9 | None |
| EMA | 8 | 2 |
| ZLG (DE) | None | 14 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
| US FDA | None | 1 |
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