FDA Inspection 1038090 — Unit Dose Services, LLC
The FDA completed an inspection of Unit Dose Services, LLC on January 19, 2018 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 19, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dania, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |