FDA 483 - Analytical Control Systems, Inc - March 30, 2026

Analytical Control Systems, Inc. in Fishers, IN, was inspected from March 23-30, 2026, and received an FDA Form 483 with eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate documentation for risk management, process validation, equipment infrastructure, supplier evaluation, corrective actions, complaint investigations, internal audits, and management reviews. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements for medical device manufacturing.