Sanofi-Aventis Deutschland GmbH — FDA Facility Profile
Sanofi-Aventis Deutschland GmbH is an FDA-registered facility (FEI 3003195501) located in Frankfurt am Main, DE. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 11 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Mar 25, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 11 (1 OAI, 7 VAI, 3 NAI)
- Last OAI inspection
- Sep 16, 2010
- Warning letters
- 1 listed by FDA for this FEI, latest Feb 8, 2011
- Form 483 and inspection documents
- 1 in FDA's reading room
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 25, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| May 14, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 3, 2017 | Voluntary Action Indicated (VAI) | Equipment to control conditions (21 CFR 211.42(c)(10)(vi)) Validation lacking for sterile drug products (21 CFR 211.113(b)) Establish reliability of supplier's C of A (21 CFR 211.84(d)(2)) Written record of investigation incomplete (21 CFR 211.192) |
| Dec 10, 2015 | No Action Indicated (NAI) | Management review - defined interval, sufficient frequency (21 CFR 820.20(c)) |
| Jun 26, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 5, 2013 | No Action Indicated (NAI) | No citations listed |
| Jul 2, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 30, 2012 | No Action Indicated (NAI) | No citations listed |
| Jul 14, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 16, 2010 | Official Action Indicated (OAI) | No citations listed |
Form 483s and inspection documents
- Jan 16, 2025: 483 on FDA.gov
Facility details
- Company
- Sanofi-Aventis Deutschland GmbH
- Location
- Frankfurt am Main (DE)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs