FDA WARNING_LETTER - Analytical Control Systems, Inc - December 03, 2013

An FDA inspection of Analytical Control Systems, Inc. (Fishers, IN) from October 29 to December 3, 2013, revealed their in vitro diagnostic devices, including G-6-PDH and Hemoglobin controls, are adulterated due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Significant QS violations include: failure to validate manufacturing processes (21 CFR 820.75(a)), inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), failure to establish finished device acceptance procedures (21 CFR 820.80(d)) leading to non-conforming product release, inadequate device packaging/shipping (21 CFR 820.130), failure to control nonconforming product (21 CFR 820.90(a)), lack of statistically valid sampling plans (21 CFR 820.250(b)), and inadequate control over changes to specifications, procedures, and design (21 CFR 820.70(b), 820.40, 820.30(i)). Furthermore, Glucose 6 Phosphate Dehydrogenase Controls are adulterated for lacking premarket approval (21 U.S.C.  351(f)(1)(B)) and misbranded for failure to submit a 510(k) notification (21 U.S.C.  352(o)). All devices are misbranded due to inadequate Medical Device Reporting (MDR) procedures (21 CFR Part 803.17) and failure to report corrections/removals (21 CFR Part 806.10(a)(2)). The firm's response was inadequate. FDA requires prompt, systemic corrective actions within fifteen business days, with documentation and a timetable. Non-compliance may lead to regulatory actions like seizure, injunction, civil penalties, and impact on federal contracts, PMA approvals, and Certificates to Foreign Governments. Premarket clearance documentation for specific hemoglobin controls is also required.