FDA Inspection 719440 — Stauber Performance Ingredients, Inc.
The FDA completed an inspection of Stauber Performance Ingredients, Inc. on March 4, 2011 in Florida, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Florida, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15721 | 21 CFR 111.365(k) | Processing lines, major equipment - contents |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15803 | 21 CFR 111.560(c) | Product complaint -investigate, findings, follow-up |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 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 |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15950 | 21 CFR 111.110(b) | Quality control operations - tests, examinations |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 16020 | 21 CFR 111.140 (b)(3)(ii) | Material review, disposition, follow-up; investigation |
| 16037 | 21 CFR 111.605 | Records - keep: 1 year, 2 years |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |