FDA Inspection 835726 — Pure Herbs Ltd
The FDA completed an inspection of Pure Herbs Ltd on May 31, 2013 in Sterling Heights, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 31, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sterling Heights, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15597 | 21 CFR 111.160(c)(3) | Labels - quality control; approve, release |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15772 | 21 CFR 111.415(g) | Representative sample - packaged, labeled dietary supplement |
| 15788 | 21 CFR 111.410(a) | Packaging - specifications |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15849 | 21 CFR 111.73 | Specifications met - contamination limits |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |