FDA EIR - Streck, Inc. - September 20, 2018

Streck, a Class I and II medical device manufacturer in La Vista, NE, underwent a "For Cause" FDA inspection from September 17-20, 2018. Conducted under Compliance Program 7382.845, the inspection evaluated the firm's quality system, medical device reporting, and product distribution, focusing on Cyto-Chex and Cell Free DNA (Research Use Only) tubes. The FDA issued a 3-item Form 483, detailing main violations. First, design controls for Cyto-Chex blood collection tubes were deemed inadequate, specifically regarding documentation for inert materials, mitigation of interfering substances (extractables/outgassing), and verification/validation testing of these issues (21 CFR 820.30(c)). Second, finished device acceptance procedures were deficient, lacking direct test methods and acceptance criteria for K3-EDTA concentration in the final Cyto-Chex product (21 CFR 820.80(d)). Third, complaint investigations for Cell Free DNA RUO tubes were inadequate, as the firm failed to investigate incidents suggesting clinical use, thus not ensuring appropriate product application (21 CFR 820.198(e)). Verbal observations included improper labeling (missing a prescription use statement) and concerns about risk assessment conservatism. Management was warned of their responsibilities to adhere to the Food, Drug, and Cosmetics Act, requiring the firm to address these observations.