867773
Pristine Bay LLC — FEI 3004476935
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- West Chester, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15815 | 21 CFR 111.570(b)(2)(ii)(D) | Record - product complaint; nature, how used |
| 15816 | 21 CFR 111.570(b)(2)(ii)(E) | Record - product complaint; reply |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15934 | 21 CFR 111.105(c) | Quality control - basis; in-process, component, specifications |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16044 | 21 CFR 111.503 | Written procedures - returned dietary supplement; salvaged |
| 16052 | 21 CFR 111.530 | Returned dietary supplement - investigation |