FDA Inspection 1017776 — United 1 Laboratories Manufacturing, LLC DBA Protec Laboratory
The FDA completed an inspection of United 1 Laboratories Manufacturing, LLC DBA Protec Laboratory on July 13, 2017 in Quitman, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 13, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Quitman, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |