FDA Inspection 1260950 — Woosuk Ent., Corp
The FDA completed an inspection of Woosuk Ent., Corp on Jan 23, 2025 in Saipan, MP. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 23, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Saipan, MP (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 22809 | 21 CFR 111.353 | Written procedures - establish; manufacturing operations |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22815 | 21 CFR 111.8 | Written procedures - establish; personnel |
| 22827 | 21 CFR 111.16 | Written procedures - establish; cleaning |
| 22834 | 21 CFR 111.25 | Equipment - establish written procedures |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22844 | 21 CFR 111.70(c)(1) | In-process specification |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22870 | 21 CFR 111.153 | Written procedures - establish; components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |