FDA 483 - Kattegat Llc - October 13, 2021

An FDA inspection of Kattegat Llc, a medical device distributor in Valley Stream, NY, revealed significant deficiencies in their quality system. The firm failed to maintain complaint files, establish design control procedures, and implement adequate supplier oversight for their (b)(4) compression sock. These observations indicate a lack of fundamental controls necessary for ensuring device quality and regulatory compliance.