FDA Inspection
Chembio Diagnostic Systems, IncChembio Diagnostic Systems, Inc – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns Chembio Diagnostic Systems, Inc, with an inspection on March 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 40cc9a2a-e4f2-4899-99d8-880420452550
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1045424
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.80(e)Documentation
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Other FDA inspections of Chembio Diagnostic Systems, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2026 | Not classified | New York District Office | |
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 19, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 1, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Chembio Diagnostic Systems, Inc
- FDA Inspection 1333204 - 2026-07-21
- FDA Inspection 1193511 - 2022-12-14
- FDA Inspection 1003834 - 2016-08-19
- FDA Inspection 684143 - 2010-10-01
- FDA Inspection 583100 - 2009-05-08
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