FDA Inspection 778734 — Beekley Corporation
The FDA completed an inspection of Beekley Corporation on May 3, 2012 in Bristol, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bristol, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |