FDA Inspection 853282 — Naprodis, Inc.
The FDA completed an inspection of Naprodis, Inc. on October 25, 2013 in Escondido, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 25, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Escondido, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |