FDA WARNING_LETTER - Kronner Prototypes, Inc. dba Kronner Medical - February 04, 2013

On February 1-4, 2013, an FDA inspection of Kronner in Roseburg, Oregon, revealed that their Kronner Side-Kick, a Perineal Instrument Holder, is an adulterated device under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) good manufacturing practice requirements.

Violations include: 1. **Failure to establish and maintain purchasing controls (21 CFR 820.50):** The firm lacked procedures and a written agreement with the contract manufacturer of sterile gas tubing. The firm's response, stating documentation would be established in 2-6 months, was inadequate as it lacked interim corrections and supporting documentation. 2. **Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** The firm admitted to lacking CAPA procedures. Their response, promising documented procedures "as soon as possible," was inadequate due to no timeframe, interim corrections, or supporting documentation. 3. **Failure to establish and maintain design change procedures (21 CFR 820.30(i)):** The firm lacked procedures for design changes, despite making at least two to the Kronner Side-Kick since 2009 (control knob changes, luer guard