FDA Inspection
RhythmedixRhythmedix – FDA Inspection, May 27, 2016
Record Details
This FDA Inspection record concerns Rhythmedix, with an inspection on May 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rhythmedix
- Inspection Date
- May 27, 2016
- Product Type
- Devices
View Company Profile
ID · 4315e81e-4917-4b5a-b3a1-dfc8c1f5a196
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974115
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.184DHR content
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Other FDA inspections of Rhythmedix
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | Not classified | New Jersey District Office | |
| April 29, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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