FDA Inspection 1012342 — Universal Instrumentation, LLC
The FDA completed an inspection of Universal Instrumentation, LLC on June 1, 2017 in Dallas, TX. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |