FDA Inspection
Ward Photonics, LLCWard Photonics, LLC – FDA Inspection, Apr 18, 2019
Record Details
This FDA Inspection record concerns Ward Photonics, LLC, with an inspection on April 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 48264501-1f4d-4305-904d-153c859853df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086770
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Ward Photonics, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 19, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ward Photonics, LLC
- FDA Inspection 1340790 - 2026-10-07
- FDA Inspection 1195703 - 2023-01-19
- FDA Inspection 946142 - 2015-10-21
- FDA Inspection 825330 - 2013-03-27
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