Miguel Arean E Hijos, S.L. — FDA Facility Profile
Miguel Arean E Hijos, S.L. is an FDA-inspected facility (FEI 3005090177) located in Chantada, ES. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 12, 2022: No Action Indicated (NAI)
- Inspections on record
- 5 (1 OAI, 2 VAI, 2 NAI)
- Last OAI inspection
- Sep 22, 2017
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 12, 2022 | No Action Indicated (NAI) | Closure defects - Corrective actions taken and recorded (21 CFR 113.60(a)) Coding - no mark, permanently visible (21 CFR 113.60(c)) |
| Sep 22, 2017 | Official Action Indicated (OAI) | Process filing (21 CFR 108.35(c)(2)) |
| Apr 19, 2016 | No Action Indicated (NAI) | Other systems - records; critical factors (21 CFR 113.100(a)(7)) Process adherence (21 CFR 108.35(c)(3)(i)) |
| Dec 16, 2014 | Voluntary Action Indicated (VAI) | Process records - forms missing information (21 CFR 113.100(a)) Coding - required elements (21 CFR 113.60(c)) Process filing (21 CFR 108.35(c)(2)) |
| Jul 11, 2013 | Voluntary Action Indicated (VAI) | Operators (21 CFR 113.10) Registration (21 CFR 108.35(c)(1)) Process filing (21 CFR 108.35(c)(2)) |
Facility details
- Company
- Miguel Arean E Hijos, S.L.
- Location
- Chantada (ES)
- Source
- inspections