FDA Inspection 1080639 — R.E.C. Manufacturing Corp.
The FDA completed an inspection of R.E.C. Manufacturing Corp. on Feb 26, 2019 in Hopedale, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 26, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hopedale, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |