FDA Inspection 1141432 — Endow Tissue LLC
The FDA completed an inspection of Endow Tissue LLC on May 5, 2021 in Carrollton, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 5, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |