Rottendorf Pharma GmbH — FDA Facility Profile
Rottendorf Pharma GmbH is an FDA-registered facility (FEI 3003732290) located in Ennigerloh, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Mar 14, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (5 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 14, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| May 6, 2021 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 21, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 3, 2017 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) |
| Mar 14, 2014 | No Action Indicated (NAI) | No citations listed |
| Mar 30, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Rottendorf Pharma Gmbh
- Location
- Ennigerloh (DE)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs