Baltimore Dominicana S.A. — FDA Facility Profile
Baltimore Dominicana S.A. is an FDA-inspected facility (FEI 3001622682) located in Santiago. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Mar 10, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (3 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
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 10, 2023 | Voluntary Action Indicated (VAI) | Process preventive controls - Implement (21 CFR 117.135(a)(1)) Process preventive controls - Appropriate (Adequate) (21 CFR 117.135(c)(1)) Scheduled process (21 CFR 114.80(a)(1)) Processing and production - required information (21 CFR 114.100(b)) |
| Sep 27, 2017 | Voluntary Action Indicated (VAI) | Plant construction and design (21 CFR 117.20(b)) |
| Dec 18, 2012 | Voluntary Action Indicated (VAI) | Q.C. instrument accuracy, maintenance (21 CFR 110.40(f)) Screening (21 CFR 110.20(b)(7)) Running water at suitable temperature (21 CFR 110.37(e)) As source of contamination (21 CFR 110.37(b)(3)) and 5 more |
Facility details
- Company
- Baltimore Dominicana S.A.
- Location
- Santiago
- Source
- inspections