Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Bioniche Pharma Group Ltd. Pointe-Claire, QC Canada (4/4). Reviewed a product brochure (MLC203 Rev A) for Sotradecol. Misbranded: The brochure is false and misleading as it presents many efficacy and safety claims, but fails to reveal material facts. It minimizes the risks associated with Sotradecol treatment, broadens the indication, includes unsubstantiated claims and presents misleading graphics. The brochure states, "FDA-approved Sotradecol by Bioniche Pharma is now available in the U.S. market, which guarantees safety compared to compounded forms that may not meet FDA standards and are not guaranteed." FDA says it may be acceptable to promote the advantages of an approved product, but the idea that FDA approval guarantees safety, particularly without an appropriate risk presentation, "misleadingly implies that treatment with Sotradecol is without risk," etc. (Sotradecol); FDCA 352(a) and 321(n) (No Code)http://www.fda.gov/foi/warning_letters/g5802d.pdf
Ferno-Washington, Inc. Wilmington, OH (4/7). Inspected 9/26-30/05. GMP deviations, adulterated, misbranded: Company failed to ensure that all complaints are evaluated to determine whether they must be filed as a Medical Device Report. For example, the company’s "Guide for Determining if MDR Required" required that "Cot folded more than two notches (or four inches)" is the type of event that should be reported to FDA as a Medical Device reportable event, yet seven of such events were recorded on the Return Material Authorizations, and none was reported to FDA. Design outputs were not complete, in that the service manual for the stretcher was not yet written. There were over 300 open complaints that have been open longer than three months due to the fact that there are not enough personnel in the Quality Department to review and close them, etc. (emergency medical devices: ambulance transporters, wheeled stretchers, and cots); FDCA 501(h), 502(t)(2), 21CFR 820.198(a), 820.100(a)(1), 820.30(j), 820.20(b)(2), 803.18(b)(1)(I), 803.50(a)(2), 803.17(a)(1) (CIN-06-28379-11)http://www.fda.gov/foi/warning_letters/g5804d.pdf Resonance Technology, Inc. Northridge, CA (4/13). Inspected 1/26-27. QSR deviations, adulterated: The firm has no written documentation describing the overall intentions and direction of the organization with quality, as established by management with executive responsibility. The firm does not have established procedures for handling complaints. It has no documentation describing evaluation of potential causes of nonconforming product or other quality problems once they have been identified, etc. (audio visual systems for patients undergoing magnetic resonance imaging); FDCA 501(h), 21CFR 820.20(a)&(c)&(d)&(e), 820.5, 820.22, 820.100, 820.70(c), 820.198, 820.198(a)(3) (W/L 18-06)