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FDA Inspection 1310144 — Analytical Control Systems, Inc

Analytical Control Systems, Inc — FEI 1825740

The FDA completed an inspection of Analytical Control Systems, Inc on March 30, 2026 in Fishers, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 30, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Fishers, IN (United States)

Citations

IDCFRDescription
23019ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
23060ISO 13485:2016 Clause 5.6.1Management review procedures not documented
23076ISO 13485:2016 Clause 6.3Requirements for infrastructure not documented
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23169ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented
23216ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
23221ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
23258ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented

Facility

Other inspections at this facility

  • 1113589 (VAI Thu Dec 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988040 (VAI Fri Sep 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959636 (OAI Mon Feb 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857974 (OAI Tue Dec 03 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 653375 (VAI Mon Mar 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources