FDA Inspection
Neomedix CorporationNeomedix Corporation – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns Neomedix Corporation, with an inspection on March 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Jacqueline M. Bowling (Issuing Officer)
- Kirtida Patel (Issuing Officer)
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ID · d4346570-ae2d-4318-9e89-2f29cc46695d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047029
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.130Packaging
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Neomedix Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 29, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neomedix Corporation
- FDA Inspection 1098182 - 2019-06-19
- FDA Inspection 896544 - 2014-09-19
- FDA Inspection 761781 - 2011-12-29
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