Company
United StatesSynapse Biomedical Inc, Oberlin, OH – FDA Inspections
Inspection records and compliance data for Synapse Biomedical Inc in Oberlin, Ohio. 5 FDA inspections on record (1 OAI), last inspected January 18, 2023.
Company Profile
This profile covers Synapse Biomedical Inc based in Oberlin, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 11, 2010. Last inspected January 18, 2023.
Most cited issue areas
- No financial disclosure info in investigator agreement1 inspection
- No investigation agreement statement of commitment1 inspection
- Sponsor progress reports for significant risk study1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 18, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1195865 |
| October 7, 2020 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1130955 |
| December 5, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 906473 |
| November 5, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 807042 |
| February 11, 2010 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 644078 |
FDA documents
Form 483s (1)
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Company Information
Name
Synapse Biomedical Inc
FEI Number
3005868392
Address
300 Artino St, Oberlin, Ohio 44074, United States
Country
United States
ID: ffbb8a14-9251-4211-b7e8-f97b89f8b9dc