FDA Inspection 1035530 — Baker's Best Health Products, Inc.
The FDA completed an inspection of Baker's Best Health Products, Inc. on December 20, 2017 in Wixom, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 20, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Wixom, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15605 | 21 CFR 111.165(c) | Product received - quarantine |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15920 | 21 CFR 111.95(b)(1) | Records - established specifications |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |