FDA Inspection
Midwest Sterilization CorporationMidwest Sterilization Corporation – FDA Inspection, Feb 16, 2024
Record Details
This FDA Inspection record concerns Midwest Sterilization Corporation, with an inspection on February 16, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e54c55d2-f5c9-4acd-bb2b-4339ef146eff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230329
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.180Availability
Full citation text and observation details available on the Dashboard.
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 |
| November 10, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2021 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 7, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| March 22, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Midwest Sterilization Corporation
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.