FDA Inspection 791570 — Healthwest Minerals Inc
The FDA completed an inspection of Healthwest Minerals Inc on June 26, 2012 in Chehalis, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 26, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chehalis, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |