FDA Inspection 797251 — Maine Natural Health, Inc.
The FDA completed an inspection of Maine Natural Health, Inc. on August 29, 2012 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |