FDA Inspection 1053610 — Internacional Farmaceutica Argentina SA
The FDA completed an inspection of Internacional Farmaceutica Argentina SA on May 16, 2018 in Buenos Aires. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Buenos Aires (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15437 | 21 CFR 111.15(a)(1) | Grounds - equipment, litter, weeds |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |