FDA Inspection 546390 — Brymill Corporation
The FDA completed an inspection of Brymill Corporation on November 7, 2008 in Ellington, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 7, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ellington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3162 | 21 CFR 820.184(b) | Quantity manufactured |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |