FDA Inspection
First Source IncFirst Source Inc – FDA Inspection, Jun 24, 2026
Record Details
This FDA Inspection record concerns First Source Inc, with an inspection on June 24, 2026, issued by the New York District Office, covering medical devices & rad health.
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ID · 93041924-0d43-49eb-9f3a-a5debc22a61f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1323488
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of First Source Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 20, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for First Source Inc
- FDA Inspection 1218835 - 2023-09-19
- FDA Inspection 1146675 - 2021-07-20
- FDA Inspection 1053905 - 2018-05-25
- FDA Inspection 987330 - 2016-06-10
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