FDA Inspection
Microfit, Inc.Microfit, Inc. – FDA Inspection, Aug 20, 2018
Record Details
This FDA Inspection record concerns Microfit, Inc., with an inspection on August 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d5763744-3647-484f-9931-1e7fb92973cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063445
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Microfit, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2023 | Not classified | San Francisco District Office | |
| May 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Microfit, Inc.
- FDA Inspection 1208583 - 2023-05-24
- FDA Inspection 927254 - 2015-05-27
- FDA Inspection 752333 - 2011-11-09
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