FDA WARNING_LETTER - Carousel Solutions LLC dba Xtract Solutions - April 24, 2014

An FDA inspection conducted from April 21-24, 2014, at a firm in Portland, Oregon, identified that the firm, a specification developer of Syringe Key and ER-SHOT devices, failed to conform with the Quality System (QS) regulation (21 CFR Part 820). This resulted in the devices being deemed adulterated under section 501(h) of the Act. The inspection revealed significant deficiencies across multiple critical quality system elements. Violations included the failure to establish and maintain procedures for design requirements (21 CFR 820.30(c)), design verification (21 CFR 820.30(f)), design validation (21 CFR 820.30(g)), and translating design into production specifications (21 CFR 820.30(h)). Additionally, the firm failed to control documents (21 CFR 820.40), ensure purchased products and services conform to requirements (21 CFR 820.50), establish adequate sampling methods (21 CFR 820.250(b)), and conduct quality audits (21 CFR 820.22). The firm's responses to the FDA 483 observations were largely deemed inadequate. The FDA requires prompt corrective actions within fifteen business days, including documentation and a timetable for systemic changes. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments.