FDA Inspection 1116418 — Unit Dose Services, LLC
The FDA completed an inspection of Unit Dose Services, LLC on January 31, 2020 in Dania, FL. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 31, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dania, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |