FDA Inspection 855710 — AMS Health Sciences, LLC
The FDA completed an inspection of AMS Health Sciences, LLC on December 17, 2013 in Oklahoma City, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 17, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15880 | 21 CFR 111.75(f)(2) | Label - visual examination, review supplier's documentation |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |