Inspections, Compliance, Enforcement, and Criminal Investigations
2006 Warning Letters
* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|January 10, 2006||CareFore Medical Incorporated [ARCHIVED]||Kansas City District Office||CGMP/QSR/Medical Device Reporting/Adulterated||N/A *|
|January 09, 2006||Prodesse, Inc. [ARCHIVED]||Center for Devices and Radiological Health||Lacks Premarket Approval Application/Adulterated||N/A *|
|January 08, 2006||Trim International, Inc. [ARCHIVED]||Florida District Office||Labeling/Promotional Claims False & Misleading/New Drug/Misbranded||N/A *|
|January 05, 2006||Gambro Dasco S.p.a. [ARCHIVED]||Center for Devices and Radiological Health||Current Good Manufacturing Practice Regulation/Adulterated||N/A *|
|January 05, 2006||Haemacure Corporation [ARCHIVED]||Florida District Office||QSR For Medical Device/Adulterated||N/A *|
|January 03, 2006||Theken Spine LLC [ARCHIVED]||Cincinnati District Office||Quality System Regulatory Adulterated/Misbranded||N/A *|