FDA Inspection
First Article IncFirst Article Inc – FDA Inspection, Jul 21, 2026
Record Details
This FDA Inspection record concerns First Article Inc, with an inspection on July 21, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.
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ID · b8450b42-15d8-409c-be94-033e627c0a84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1327264
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.6(c)Calibration status of measuring equipment not identified
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Other FDA inspections of First Article Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for First Article Inc
- FDA Inspection 1191151 - 2022-10-20
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