FDA Inspection 749889 — Procesadora Mejia S.A.
The FDA completed an inspection of Procesadora Mejia S.A. on Sep 20, 2011 in Guayaquil. 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). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 20, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food and Color Additives Petition Review
- Location
- Guayaquil (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1500 | 21 CFR 113.89 | Evaluation by process authority |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1732 | 21 CFR 113.40(a)(2)(i) | Range, chart graduations |
| 1733 | 21 CFR 113.40(a)(2)(i) | Scale, chart |
| 3653 | 21 CFR 110.37(d) | Readily accessible |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4479 | 21 CFR 108.25(e) | Recall procedures |