China Daheng Group Inc. – FDA Warning Letter, Jul 19, 2013
On January 15, 2014, the FDA issued a Warning Letter to China Daheng Group, Inc. following an inspection from July 15-19, 2013, which identified significant violations related to their surgical powered laser instruments (Denlase and Penlase). These products are classified as devices and electronic products subject to FDA regulations.
The inspection revealed deficiencies with performance standards (21 CFR 1010, 1040.10, 1040.11) and the Quality System (QS) regulation (21 CFR 820). Specific violations include: 1. Failure to provide calibration procedures to purchasers (21 CFR 1040.11(a)(2)). 2. Failure to attach a certification statement on the product (21 CFR 1010.2). 3. Failure to submit annual reports (21 CFR 1002.13). 4. Failure to include required controls, adjustments, and warning statements in user information (21 CFR 1040.10(h)(1)(iv)). 5. Failure to include a reproduction of the warning logotype label on sales brochures (21 CFR 1040.10(h)(2)(i)).
Additionally, Quality System regulation nonconformities were noted: 1.
ID · cc0fda17-a831-4874-99ba-e8cbf60b4d88
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