FDA Inspection
First Source IncFirst Source Inc – FDA Inspection, Jun 10, 2016
Record Details
This FDA Inspection record concerns First Source Inc, with an inspection on June 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- First Source Inc
- Inspection Date
- June 10, 2016
- Product Type
- Devices
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ID · f9ea2c06-ac6c-482a-bb31-e759e832254b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987330
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of First Source Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2026 | NAI | New York District Office | Postmarket Assurance: Devices |
| 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 |
Other documents for First Source Inc
- FDA Inspection 1323488 - 2026-06-24
- FDA Inspection 1218835 - 2023-09-19
- FDA Inspection 1146675 - 2021-07-20
- FDA Inspection 1053905 - 2018-05-25
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