FDA Inspection
Midwest Sterilization CorporationMidwest Sterilization Corporation – FDA Inspection, Nov 7, 2018
Record Details
This FDA Inspection record concerns Midwest Sterilization Corporation, with an inspection on November 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 98afdc30-f681-4c15-8644-7197047258a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071153
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Midwest Sterilization Corporation
8| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2026 | Not classified | Kansas City District Office | Project Evaluation: Devices |
| February 16, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2021 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 22, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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