FDA Inspection 766964 — Unilab Of Dade, Inc.
The FDA completed an inspection of Unilab Of Dade, Inc. on Feb 10, 2012 in Fort Lauderdale, FL. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 10, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |