GP Grenzach Produktions GmbH — FDA Facility Profile
GP Grenzach Produktions GmbH is an FDA-inspected facility (FEI 3006308309) located in Grenzach-Wyhlen, DE. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jan 30, 2018: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- 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
- 7
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 30, 2018 | Voluntary Action Indicated (VAI) | Computer control of master formula records (21 CFR 211.68(b)) Validation lacking for sterile drug products (21 CFR 211.113(b)) Quality control unit review of records (21 CFR 211.192) Complete Test Data (21 CFR 211.194(a)(4)) |
| Jul 1, 2016 | Voluntary Action Indicated (VAI) | Training , Education , Experience overall (21 CFR 211.25(a)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Validation lacking for sterile drug products (21 CFR 211.113(b)) and 7 more |
Facility details
- Company
- GP Grenzach Produktions GmbH
- Location
- Grenzach-Wyhlen (DE)
- Source
- inspections