FDA Inspection 736221 — Vitaquest International LLC d/b/a State Nutritionals, Inc.
The FDA completed an inspection of Vitaquest International LLC d/b/a State Nutritionals, Inc. on August 31, 2011 in West Caldwell, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- West Caldwell, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15718 | 21 CFR 111.375(a) | Records-manufacturing operation:originals,copies,electronic |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |
| 15960 | 21 CFR 111.113(b)(1) | Quality control - dietary supplement; adulteration |
| 16011 | 21 CFR 111.140(a) | Records - quality control operations: electronic |