FDA Inspection 793653 — Algaen Corporation
The FDA completed an inspection of Algaen Corporation on August 1, 2012 in Winston Salem, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 1, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Winston Salem, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15409 | 21 CFR 111.14(b)(1) | Personnel - records - written procedures |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15715 | 21 CFR 111.375(b) | Records - manufacturing operations; written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |