FDA Inspection
Analytical Control Systems, IncAnalytical Control Systems, Inc – FDA Inspection, Mar 30, 2026
Record Details
This FDA Inspection record concerns Analytical Control Systems, Inc, with an inspection on March 30, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Inspection Date
- March 30, 2026
- Product Type
- Medical Devices & Rad Health
- Office
- Detroit District Office
View Company Profile
ID · 569c1cef-260d-425d-a987-e35e9a9b2adb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1310144
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
10- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 6.3Requirements for infrastructure not documented
- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
- ISO 13485:2016 Clause 7.5.8Procedures for validation of processes not documented
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 4.1.3Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Analytical Control Systems, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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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