FDA Inspection 899629 — R&D Engineering, Inc. Of Earlham
The FDA completed an inspection of R&D Engineering, Inc. Of Earlham on Oct 10, 2014 in Earlham, IA. 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
- Oct 10, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Earlham, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |