FDA Inspection
Analytical Control Systems, IncAnalytical Control Systems, Inc – FDA Inspection, Dec 3, 2013
Record Details
This FDA Inspection record concerns Analytical Control Systems, Inc, with an inspection on December 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 3, 2013
- Product Type
- Devices
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ID · 904e1cfb-20bb-4083-a117-b6789c3852a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 857974
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.130Packaging
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Showing 10 of 12 citations.
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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 |
| December 19, 2019 | VAI | Center for Devices and Radiological Health | Compliance: 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 |
| March 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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