FDA Inspection
Ward Photonics, LLCWard Photonics, LLC – FDA Inspection, Jan 19, 2023
Record Details
This FDA Inspection record concerns Ward Photonics, LLC, with an inspection on January 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6017528-c128-4a9f-a1ca-46d8dc9fb953
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195703
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
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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 |
| April 18, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1086770 - 2019-04-18
- FDA Inspection 946142 - 2015-10-21
- FDA Inspection 825330 - 2013-03-27
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