FDA Inspection 990085 — Apicola De Allende, S.A. De C.V.
The FDA completed an inspection of Apicola De Allende, S.A. De C.V. on Aug 19, 2016 in Allende. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 19, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Allende (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |