FDA Inspection 852453 — S.K. Laboratories, Inc.
The FDA completed an inspection of S.K. Laboratories, Inc. on November 18, 2013 in Anaheim, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 18, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15580 | 21 CFR 111.155(c)(2) | Quality control - components; tests, examination results |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15852 | 21 CFR 111.73 | Specifications met - labels, packaging |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15874 | 21 CFR 111.75(c)(4) | Documentation - specifications met; basis, quality control |