FDA Inspection 983528 — SNAC System Inc.
The FDA completed an inspection of SNAC System Inc. on August 29, 2016 in San Carlos, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 29, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Carlos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15755 | 21 CFR 111.205(c) | Master manufacturing record: readily available |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |