FDA Inspection 836556 — Sterling USA Nutraceuticals Lab, LLC
The FDA completed an inspection of Sterling USA Nutraceuticals Lab, LLC on Jun 11, 2013 in Glendale, 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). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16067 | 21 CFR 111.35(b)(1)(ii) | Procedures - equipment; calibrating, inspecting, checking |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |