FDA WARNING_LETTER - Acrostak Schweiz AG - June 15, 2023

The FDA issued a Warning Letter to Stegackerstrasse 14, Winterthur, Switzerland, following a June 12-15, 2023, inspection. The firm manufactures the M-Cath Microcatheter (510(k) cleared, K171176) and the M-Cath Flexy Microcatheter.

The M-Cath Flexy Microcatheter, introduced in 2021, was marketed without a new 510(k) clearance despite significant design changes (different materials, additional braided layer, different tip, longer length) that could affect safety and effectiveness, including potential adverse patient reactions, vessel damage, or embolism. This renders the M-Cath Flexy Microcatheter misbranded under 21 U.S.C. § 352(o) and adulterated under 21 U.S.C. § 351(f)(1)(B).

The inspection also revealed Quality System regulation violations (21 CFR Part 820), including: 1. **Failure to monitor and control process parameters for validated processes (21 CFR 820.75(b)(2)):** The firm failed to monitor particle counts in its ISO Class 8 cleanroom during normal operations and did not adequately document process monitoring data for manufacturing. 2. **Failure to establish and maintain design validation procedures (21 CFR