FDA Inspection 1066756 — Genecell International, LLC
The FDA completed an inspection of Genecell International, LLC on Sep 19, 2018 in Doral, FL. 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)
- End Date
- Sep 19, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |