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FDA Inspection
•Analytical Control Systems, Inc•March 22, 2010

Analytical Control Systems, Inc – FDA Inspection, Mar 22, 2010

Record Details

This FDA Inspection record concerns Analytical Control Systems, Inc, with an inspection on March 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Analytical Control Systems, Inc
Inspection Date
March 22, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 20b16052-b26c-4f21-a35f-8cff8a79e465

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
653375
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
  2. 21 CFR 820.22Quality Audit/Reaudit - conducted
  3. 21 CFR 820.100(a)(1)Procedure for analysis of data sources

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Analytical Control Systems, Inc

5
DateClassificationOfficeProject area
March 30, 2026VAIDetroit District OfficeCompliance: Medical Devices
December 19, 2019VAICenter for Devices and Radiological HealthCompliance: Devices
September 30, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
February 29, 2016OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
December 3, 2013OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Analytical Control Systems, Inc
  • FDA Inspection 1310144 - 2026-03-30
  • FDA Inspection 1113589 - 2019-12-19
  • FDA Inspection 988040 - 2016-09-30
  • FDA Inspection 959636 - 2016-02-29
  • FDA Inspection 857974 - 2013-12-03

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