FDA Inspection 811131 — Baltimore Dominicana S.A.
The FDA completed an inspection of Baltimore Dominicana S.A. on Dec 18, 2012 in Santiago. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santiago (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1701 | 21 CFR 110.80(b)(7) | Equipment, containers, utensils |
| 3085 | 21 CFR 114.100(a) | Raw materials, packaging, finished product |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4475 | 21 CFR 108.25(c)(3)(i) | Process adherence |
| 4511 | 21 CFR 108.25(f) | Approved school |