FDA Inspection 1048187 — Cape Fear Naturals, LLC
The FDA completed an inspection of Cape Fear Naturals, LLC on Apr 13, 2018 in Wilmington, NC. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 13, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wilmington, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16045 | 21 CFR 111.503 | Written procedures returned dietary supplement; reprocessing |