Meiji Pharma Spain — FDA Facility Profile
Meiji Pharma Spain is an FDA-registered facility (FEI 3003184440) located in Alcala de Henares Madrid, ES. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Dec 15, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (1 OAI, 3 VAI)
- Last OAI inspection
- Jul 22, 2011
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 24, 2012
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 15, 2016 | Voluntary Action Indicated (VAI) | Production processes (21 CFR 820.70(a)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Dec 12, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 22, 2012 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Written procedures not established/followed (21 CFR 211.67(b)) input/output verification (21 CFR 211.68(b)) and 1 more |
| Jul 22, 2011 | Official Action Indicated (OAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Equipment Design, Size and Location (21 CFR 211.63) Procedures for non-sterile drug products (21 CFR 211.113(a)) Failing drug products not rejected (21 CFR 211.165(f)) and 3 more |
Facility details
- Company
- Tedec-Meiji Farma, S.A.
- Location
- Alcala de Henares Madrid (ES)
- Source
- device