FDA Inspection 1234113 — Steri-Tek, LLC
The FDA completed an inspection of Steri-Tek, LLC on March 26, 2024 in Lewisville, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lewisville, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |