FDA Inspection
Analytical Control Systems, IncAnalytical Control Systems, Inc – FDA Inspection, Feb 29, 2016
Record Details
This FDA Inspection record concerns Analytical Control Systems, Inc, with an inspection on February 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 29, 2016
- Product Type
- Devices
View Company Profile
ID · b2b5ee0c-83c8-4e09-8f01-c914a24cee6e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 959636
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.130Packaging
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
Other documents for Analytical Control Systems, Inc
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.