FDA Inspection 1100556 — Evologics, LLC
The FDA completed an inspection of Evologics, LLC on August 27, 2019 in San Antonio, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |
| 12458 | 21 CFR 1271.320(b) | Designated complaint file |
| 12470 | 21 CFR 1271.350(a)(2) | 15 day reporting timeframe |