FDA Inspection 680747 — Trent Arsenault
The FDA completed an inspection of Trent Arsenault on September 16, 2010 in Fremont, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 16, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |