FDA Inspection
Nytone Medical Products, Inc.Nytone Medical Products, Inc. – FDA Inspection, Jun 5, 2017
Record Details
This FDA Inspection record concerns Nytone Medical Products, Inc., with an inspection on June 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · c94cca0e-a6c3-449b-af33-adf86e36f022
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012840
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nytone Medical Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 5, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Nytone Medical Products, Inc.
- FDA Inspection 861881 - 2014-01-10
- FDA Inspection 588881 - 2009-06-05
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.