FDA WARNING_LETTER - Mundt & Associates, Inc. - March 30, 2010

The FDA issued a Warning Letter to Mundt & Associates, Inc. following a March 30, 2010 inspection and review of product and annual reports, leading to the disapproval of their quality control and testing program for all laser products, including Models IB-1284 and GT-1000. This action, under the Federal Food, Drug, and Cosmetic Act, prohibits the firm from certifying, introducing, or importing non-compliant or uncertified electronic products into U.S. commerce.

Violations include: 1. **21 CFR 1010.2(c) Certification:** Failure to certify laser products based on a testing program in accordance with good manufacturing practices, lacking manufacturing quality test records. Improper classification of the "Hayward" Filter Cutting Laser System, which incorporates a Class IV laser with inadequate enclosure for Class I standards. 2. **21 CFR 1002.30(a)(1-4) Records:** Failure to maintain records of quality control procedures for radiation safety, test results for radiation safety, durability and stability tests, and communications concerning radiation safety. 3. **21 CFR 1002.10 Product Reports:** Failure to submit product reports for all manufactured products (only 6 of 19 submitted since January 2005) and inadequate identification of products in submitted reports. 4. **21 CFR 10