FDA Inspection 781823 — Pure Herbs Ltd
The FDA completed an inspection of Pure Herbs Ltd on May 24, 2012 in Sterling Heights, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 24, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sterling Heights, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |