FDA Inspection 1045424 — Chembio Diagnostic Systems, Inc
The FDA completed an inspection of Chembio Diagnostic Systems, Inc on Mar 23, 2018 in Medford, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Medford, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |