FDA WARNING_LETTER - A-Solutions, Inc. - July 02, 2007

An FDA inspection of A-Solutions, Inc. (Louisville, KY) from June 13 to July 2, 2007, revealed significant violations for its reusable and disposable sharps containers, classified as medical devices. The devices were adulterated under 21 U.S.C. § 351(h) due to non-compliance with Quality System (QS) regulation (21 CFR Part 820).

Key QS deficiencies included: inadequate management controls (missing/unimplemented procedures, no quality policy), failure to conduct quality audits, lack of written corrective and preventive action procedures, inadequate complaint handling, incomplete Device Master Records (DMR), missing Device History Records (DHR), no servicing instructions, inadequate distribution records, and insufficient design and purchasing controls.

Furthermore, the reusable sharps container was adulterated under 21 U.S.C. § 351(f)(1)(B) as significant design changes were made without a new 510(k) submission. Devices were also misbranded under 21 U.S.C. § 352(o) for failure to notify the agency of intent to market, and for improper establishment registration (21 CFR 807.25(b)) and device listing (21 CFR 807.20(a)) as a manufacturer/specification developer. Labeling misbranding (21 U.S.C. § 252(b), 21 CFR 801.1) was cited for lacking manufacturer's name and place of business.

The firm's response was largely inadequate, requiring detailed corrective actions and timelines within fifteen working days. Non-compliance could lead to regulatory actions like seizure, injunction, civil money penalties, and impact on federal contracts and device approvals.