FDA Inspection 613871 — Pure Encapsulations, LLC
The FDA completed an inspection of Pure Encapsulations, LLC on September 22, 2009 in Sudbury, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 22, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Sudbury, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15751 | 21 CFR 111.210(d) | Master manufacturing record - Supplemental Facts |
| 15815 | 21 CFR 111.570(b)(2)(ii)(D) | Record - product complaint; nature, how used |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15929 | 21 CFR 111.103 | Written procedures - quality control operations, reprocessin |