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.
Health Authority LLC Orlando, FL (1/24). Reviewed Web site at www.doctorstrust.com. Misbranded: The site claims that the ISD-10 Immune System Defense is useful in preventing avian flu and other forms of influenza. These claims cause the product to be an unapproved drug. The labeling is false and misleading because its claims are not supported by competent and reliable scientific evidence. (ISD-10 Immune Defense System); FDCA 505, 502(a) (FLA-06-14)
http://www.fda.gov/foi/warning_letters/g5702d.pdf
Human Investigation Committee of Houston, TX (1/23). Inspected 5/2-5/05. IRB violations: It failed to ensure that informed consent is sought from each prospective subject or the subject's legally authorized representative. The IRB failed to have a written procedure to ensure prompt reporting to FDA of any unanticipated problems involving risks to human subjects, etc. (Clozaril study); 21CFR 56.111(a)(1)(4), 56.108(b)(1) (06-HFD-45-0120)
http://www.fda.gov/foi/warning_letters/g5700d.pdf
Mayne Pharma (USA), Inc. Paramus, NJ (2/1). Reviewed a promotional mailer for MVI-12 (multi-vitamin infusion without vitamin K). The mailer is false or misleading because is omits important risk information and misbrands the drug. The lack of risk information suggests that the product is safer than has been demonstrated by substantial evidence or clinical experience. (MVI-12); FDCA 502(a), 201(n) (No Code)
http://www.fda.gov/foi/warning_letters/g5705d.pdf
Price, David Tomball, TX (1/27). Misbranded: Unapproved new drugs: The products marketed on the Web site
http://www.fda.gov/foi/warning_letters/g5704d.pdf
RXIBR Corporation Houston, TX (1/27). Misbranded: Claims made on the Web site
ZLB Behring King of Prussia, PA (1/24). Inspected Omaha, NE facility 12/7-13/05. Company failed to defer from donation unsuitable donors such as an unreliable donor and donors with an unexplained weight loss of more than 10 pounds. Company failed to clean and/or maintain equipment used to determine donor suitability in accordance with company standard operating procedures, etc. (blood and components); FDCA 501(a)(2)(B), 21CFR 640.63(a), 606.60, 640.65(b)(1)(I), 606.100 (KAN 2006-11)
http://www.fda.gov/foi/warning_letters/g5701d.pdf
