Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Eastern Pharmacy, Inc. Ocala, FL (10/29). Inspected 1/30-2/4. Adulterated: FDA inspected firm after receiving notification from the Florida Department of Business and Professional Regulation describing serious adverse events in at least 37 patients who had received intravitreal injections of Avastin (bevacizumab) or Lucentis (ranibizumab) repackaged by Eastern Pharmacy. FDA investigators observed that the firm’s drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have been contaminated with filth or rendered injurious to health. The firm repackaged Avastin and Lucentis by completely removing the rubber stoppers from the sterile, preservative free vials, thus exposing the content to this uncontrolled environment. Investigators also observed that the firm had no door or closure installed to separate the aseptic processing area from the common pharmacy area, etc. (Avastin, Lucentis, etc.); FDCA 501(a)(2)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423249.htm
Dr. Benedict Schue-Schie Liao (a.k.a Dr. Wada Masao) West Covina, CA (7/8). Inspected facility 10/17-18/12 and 5/2/8/13-6/4/13. Reviewed Web site, www.cancertreatmentus.org (redirects to: http://oeyamamotocancerresearchfoundation.org); Unapproved new drug, misbranded: The labeling for the firm’s Allesgen product promotes it as a drug. FDA notes that “Allesgen” does not meet the requirements governing the use of investigational new drugs. Also, according to official FDA records, the firm’s INDs have never gone into effect, and were either canceled or placed on clinical hold, etc. (Allesgen); FDCA 502(a), 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm422840.htm
MKL Diagnostics AB Sollentuna, Sweden (7/29). Inspected 3/24-25. QSR deviations, adulterated, misbranded: The firm failed to establish procedures for the control of the design of the Phadebact test kits. The complaint handling procedure does not include a requirement to evaluate complaints to determine if it should be reported as a MDR. (Phadebact monoclonal GC, H. Influenza, and CSF Tests); FDCA 501(h), 502(t)(2), 21 CFR 820.30(a), 803, 820.198(a)(3)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm422834.htm
Wells Pharmacy Network, LLC Wellington, FL Inspected 7/22-26/13, 2/21-3/7, and 5/30-6/19. GMP violations, adulterated, misbranded: Investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Investigators also observed technicians wearing non-sterile gowns while performing aseptic operations. The firm does not use sporicidal agents to disinfect the ISO-5 areas. Also, it failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates, etc. (drugs); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.166(a), 211.42(c)(10)(iv)(v)), 211.28(a), 211.100(a), 210, 211
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423242.htm
Windmill Health Products, LLC West Caldwell, NJ (10/7). Inspected 6/18-7/17/13. Unapproved new drugs, misbranded: FDA also inspected the firm’s Web site at www.windmillvitamins.com in 7/2013 and again in 7/2014 and has determined that the firm takes orders there for the products Nutri-Betic caplets, Vita-betic caplets, ProstrinRx tablets, Polyflavanol capsules, and Glucoflex Joint Lube liquid. The labels and Web site promote these products for conditions that cause them to be drugs. The products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; and adequate directions cannot be written so that a layperson can use them safely for their intended uses (ProstrinRx tablets, Polyflavonol capsules, Vita-Betic caplets, Nutra-Betic caplets, Glucoflex Joint Lube liquid,); FDCA 502(f)(1), 505(a), 21 CFR 111.105, 111.453, 111.553
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423048.htm
