992993
Unit Dose Services, LLC — FEI 3010164341
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dania, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |