FDA Inspection
Proxtalker.Com, LlcProxtalker.Com, Llc – FDA Inspection, Nov 18, 2025
Record Details
This FDA Inspection record concerns Proxtalker.Com, Llc, with an inspection on November 18, 2025, issued by the New England District Office, covering medical devices & rad health.
- Person
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ID · c3ee6a8c-0249-4166-921d-59834eab27f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1292056
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Proxtalker.Com, Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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