FDA Inspection 963680 — Agro Fergi S.A.C.
The FDA completed an inspection of Agro Fergi S.A.C. on March 24, 2016 in Lima. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lima (Peru)
Citations
| ID | CFR | Description |
|---|---|---|
| 1292 | 21 CFR 110.20(b)(1) | Sufficient space |
| 1553 | 21 CFR 110.35(a) | Buildings/good repair |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |