FDA Inspection 909696 — Almased USA, Inc
The FDA completed an inspection of Almased USA, Inc on December 18, 2014 in Charlotte, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15349 | FDCA 761(d) | MedWatch form not used (dietary supplements) |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 16046 | 21 CFR 111.503 | Written procedures returned dietary supplement investigation |