CURASAN AG, FRANKFURT FACILITY — FDA Facility Profile
CURASAN AG, FRANKFURT FACILITY is an FDA-registered facility (FEI 3004847139) located in FRANKFURT Hesse, DE. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 11, 2017: Official Action Indicated (OAI)
- Inspections on record
- 1 (1 OAI)
- Last OAI inspection
- May 11, 2017
- Warning letters
- 1 listed by FDA for this FEI, latest Aug 23, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 11, 2017 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Production processes (21 CFR 820.70(a)) Lack of Written MDR Procedures (21 CFR 803.17) and 1 more |
Facility details
- Company
- Curasan AG, Frankfurt Facility
- Location
- FRANKFURT Hesse (DE)
- Source
- device