FDA Inspection 1029627 — Repro-Med Systems, Inc.
The FDA completed an inspection of Repro-Med Systems, Inc. on October 19, 2017 in Chester, NY. 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
- October 19, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |