FDA Inspection 747227 — Ranfac Corporation
The FDA completed an inspection of Ranfac Corporation on Jul 13, 2011 in Avon, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 13, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Avon, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |