Company
United StatesHemedex, Inc., Waltham, MA – FDA Inspections
Inspection records and compliance data for Hemedex, Inc. in Waltham, Massachusetts. 5 FDA inspections on record, 1 Form 483, last inspected August 19, 2026.
Company Profile
This profile covers Hemedex, Inc. based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected June 10, 2010. Last inspected August 19, 2026.
Most cited issue areas
- Complaint handling procedures not documented1 inspection
- Design and development validation not performed as planned1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 19, 2026 | NAI | · Postmarket Assurance: Devices | 1333962 |
| February 17, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1207959 |
| October 5, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028218 |
| March 14, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 822744 |
| June 10, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 667620 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hemedex, Inc.
FEI Number
3003730855
Address
564 Main St Ste 300, Waltham, Massachusetts 02452, United States
Country
United States
ID: be6a1de7-58a9-4676-9f24-3aa38a88a7f4