FDA Inspection
Monteris Medical CorpMonteris Medical Corp – FDA Inspection, Jun 30, 2016
Record Details
This FDA Inspection record concerns Monteris Medical Corp, with an inspection on June 30, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Monteris Medical Corp
- Inspection Date
- June 30, 2016
- Product Type
- Devices
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ID · fb4a23bf-a9d2-4a84-966d-a091611667a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983042
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Monteris Medical Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Monteris Medical Corp
- FDA Inspection 1067866 - 2018-10-04
- FDA Inspection 910131 - 2014-11-14
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