FDA Inspection
Midwest Products and Engineering IncMidwest Products and Engineering Inc – FDA Inspection, Apr 21, 2023
Record Details
This FDA Inspection record concerns Midwest Products and Engineering Inc, with an inspection on April 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c954fc29-f388-4da7-81f5-2af18be6b81b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203163
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Midwest Products and Engineering Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2025 | NAI | Minneapolis District Office | Postmarket Assurance: Medical Devices |
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