FDA Inspection 1149912 — Biograft Transplant Services Inc
The FDA completed an inspection of Biograft Transplant Services Inc on August 27, 2021 in Houston, 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
- August 27, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |