FDA Inspection 680484 — Tra & Accessories
The FDA completed an inspection of Tra & Accessories on September 14, 2010 in San Dimas, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 14, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Dimas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |