FDA Inspection 792112 — United Laboratories Manufacturing, LLC
The FDA completed an inspection of United Laboratories Manufacturing, LLC on Jul 17, 2012 in Dallas, TX. 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
- Jul 17, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15787 | 21 CFR 111.410(b) | Packaging - issuance, use |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 2024 | 21 CFR 211.188(b)(12) | Documentation of Batch Investigations |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |