FDA released today its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Geffen, David I. San Diego, CA (7/8). Inspected 3/20-4/1/03. Clinical investigator violations: Investigator failed to obtain study approval from the reviewing IRB prior to initiation of the study. The informed consent document used failed to include a description of all procedures to be conducted as part of the study. Investigator did not provide, either during the inspection or in his response, any documents to show that he had submitted the required progress reports, etc. (device study); 21CFR 812.110(a), 50.27(a), 50.25, 812.100, 812.110(b), 812.150(a)(3), 812.140(a) (No Code)
http://www.fda.gov/foi/warning_letters/g4126d.pdf
Roche Diagnostics Corp. Indianapolis, IN (6/11). Inspected Disetronic Medical Systems, Burgdorf, Switzerland 1/27-2/5/03. QSR deviations, adulterated: Review of the CAPA system document noted that all quality data sources have not been identified. For example, production statistics did not identify all available in-process production test data sources and the routine analysis to be performed on these data sources. Firm lacks documentation that verification or validation was performed of the corrective actions taken on H-Tron products to ensure the effectiveness of the changes. Firm also did not validate the computer software for its intended use or analyze service reports with appropriate statistical methodology, etc. (external insulin infusion pumps); FDCA 501(h), 21CFR 820.100(a)(1)(4), 820.30(g), 820.70(i), 820.75(a), 820.200(b), 820.250, 820.40(b), 820.181(b), 820.20(c) (No Code)
http://www.fda.gov/foi/warning_letters/g4120d.pdf
Zimmer Elektromedizin Neu-Ulm, Germany (6/24). Inspected 3/10-13/03. Unapproved device, GMP deviations, adulterated, misbranded: Product is intended for a use different from the intended use of a legally marketed device in the generic cold pack device category. Cooling devices intended for use with lasers are considered accessories to lasers, and are Class II devices requiring premarket notification. Also, in the manufacture of disposable therapy electrodes. Company failed to validate the packaging sealing process and the ability of the mixing process to ensure that the concentration of free acryl acid remains within specified limits. The Device Master Record and the specifications/procedures for mixing the gel do not adequately define the mixing parameters. The firm also failed to maintain adequate documentation of investigations of nonconformities and complaints or to document the reason for not performing an investigation that was the result of a complaint, etc. (Cryo 5 skin cooling system, disposable electrodes); FDCA 510(k), 502(o), 501(f)(1)(B), 501(h), 21CFR 807.81(a)(3)(ii), 820.75(a), 820.70(a), 820.100(a)(2)&(3), 820.80(d), 820.184, 820.120(b), 820.40(b), 820.22, 820.20(c) (No Code)
