FDA Inspection 1193221 — R&D Engineering, Inc. of Earlham
The FDA completed an inspection of R&D Engineering, Inc. of Earlham on December 15, 2022 in Earlham, IA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 15, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Earlham, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |