FDA Inspection 771346 — Plantas Medicinales Anahuac, S.A. De C.V.
The FDA completed an inspection of Plantas Medicinales Anahuac, S.A. De C.V. on Feb 15, 2012 in Mexico. 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). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 15, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mexico (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15428 | 21 CFR 111.15(h) | Bathrooms - clean |
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15465 | 21 CFR 111.20(d)(2) | Air blowing equipment |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |