Company
United StatesChembio Diagnostic Systems, Inc, Medford, NY – FDA Inspections
Inspection records and compliance data for Chembio Diagnostic Systems, Inc in Medford, New York. 6 FDA inspections on record, 1 Form 483, last inspected July 21, 2026.
Company Profile
This profile covers Chembio Diagnostic Systems, Inc based in Medford, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 8, 2009. Last inspected July 21, 2026.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate In-process acceptance procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2026 | Not classified | Medical Devices & Rad Health | 1333204 |
| December 14, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1193511 |
| March 23, 2018 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 1045424 |
| August 19, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003834 |
| October 1, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 684143 |
| May 8, 2009 | NAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 583100 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Chembio Diagnostic Systems, Inc
FEI Number
2431980
Address
3661 Horseblock Rd, Medford, New York 11763, United States
Country
United States
ID: ab2cef6e-48e9-4b33-805b-7b30e6ffcea5