FDA Inspection
Analytical Control Systems, IncAnalytical Control Systems, Inc – FDA Inspection, Dec 19, 2019
Record Details
This FDA Inspection record concerns Analytical Control Systems, Inc, with an inspection on December 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 19, 2019
- Product Type
- Devices
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ID · 82c5a727-be4d-4f54-9d70-811ad856ed67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113589
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Analytical Control Systems, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2026 | VAI | Detroit District Office | Compliance: Medical Devices |
| September 30, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 29, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 3, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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