FDA Inspection 601489 — DeRoyal Industries, Inc.
The FDA completed an inspection of DeRoyal Industries, Inc. on July 31, 2009 in Sanford, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 31, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2556 | 21 CFR 820.30(c) | Incomplete, ambiguous, conflicting design requirements |
| 2627 | 21 CFR 820.30(e) | Design reviews performed following schedule |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 4189 | 21 CFR 820.198(a) | General |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 771 | 21 CFR 803.52(e)(1) | Contact Office Name and Address |