Medical Compression Systems – FDA Warning Letter, Jun 23, 2011

On October 27, 2011, the FDA issued a Warning Letter to Medical Compression System (DBN) Ltd. following an inspection from June 20-23, 2011, which found their ActiveCare DVT and ActiveCare + SFT devices to be adulterated and misbranded.

The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included: 1. Failure to establish and maintain adequate procedures for design changes (21 CFR 820.30(i)), specifically regarding an (b)(4) modification without proper validation. 2. Failure to adequately review, evaluate, and investigate complaints (21 CFR 820.198(c)), exemplified by uninvestigated power supply failures. 3. Failure to process complaints uniformly and timely (21 CFR 820.198(a)(1)), with instances of significant delays in complaint creation. 4. Failure to establish and maintain adequate procedures for corrective and preventive actions (CAPA) (21 CFR 820.100(a)(3)), evidenced by inadequate resolution of recurring subcontractor issues. 5. Failure to establish and maintain adequate procedures for quality audits (21 CFR