FDA WARNING_LETTER - Topspins, Inc. - August 15, 2014

An FDA inspection of Topspins, Inc. in Ann Arbor, Michigan, from August 5-15, 2014, revealed that the firm, a specification developer and own label distributor of Smart Set intravenous tubing sets, was in violation of the Federal Food, Drug, and Cosmetic Act. The Smart Set devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to control device design (21 CFR 820.30):** Specifically, lack of procedures for identifying, documenting, validating/verifying, reviewing, and approving design changes (21 CFR 820.30(i)), and inadequate procedures for validating device design (21 CFR 820.30(g)). Multiple design changes to the Smart Set tubing (versions 001.2, 001.4, 001.5) lacked proper documentation for verification studies or justification for verification over validation. 2. **Failure to control nonconforming product (21 CFR 820.90(b)(1)):** Procedures did not require documentation of nonconformance evaluations, investigation necessity, notification of responsible parties, or authorized use justification for nonconforming products. A specific lot (CF