FDA Inspection 828668 — United Laboratories Manufacturing, LLC
The FDA completed an inspection of United Laboratories Manufacturing, LLC on Apr 22, 2013 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 22, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15976 | 21 CFR 111.123 | Quality control operations - master, batch, manufacturing |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |