FDA Inspection 1068213 — S.K. Laboratories, Inc.
The FDA completed an inspection of S.K. Laboratories, Inc. on Oct 9, 2018 in Anaheim, CA. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 9, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15799 | 21 CFR 111.560(a)(1) | Product complaint - quality control review |
| 15848 | 21 CFR 111.73 | Specifications met - component purity, strength, composition |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |