Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Alcon LenSx, Inc. Aliso Viejo, CA (12/3/12). Inspected 6/7-8/2/12. QSR deviations, adulterated (LenSx Laser System); FDCA 501(f)(1)(B), 515(a), 502(o), 21 CFR 820.100(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm339489.htm
Beehive Botanicals, Inc. Hayward, WI (2/8). Inspected 7/23-25/12. GMP violations, adulterated: It failed to establish component specifications for each component that it uses in manufacturing a dietary supplement. It also failed to establish product specifications for the identity, purity, strength, and composition for each dietary supplement it manufactures, etc. (dietary supplements); 21 CFR 111.70(b)&(e), 111.75(h)(1), 111.210, 111.315(d), 111.140(b)(3), 111.123(b)(3)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339823.htm
Discount Online Pharmacy, Nameva.com (2/11). Unapproved new drug, misbranded The firm offers for sale through its Web site, “Generic Tamiflu.”
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339540.htm
Edifacio Center El Dorado, Panama City, Panama (2/11). Reviewed Web site at www.SunDrugStore.com. Unapproved and misbranded new drugs (generic Tamiflu)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339541.htm
Kosher Vitamins Express (2/11). Reviewed Web site at www.koshervitamins.com in January. Misbranded: The Web site offers products for sale that are intended to diagnose, mitigate, prevent, treat or cure the flu virus in people. These products have not been approved or cleared by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the flu virus, etc. (Zahlers Kosher Abreve Advanced Cold & Flu Formula, Sunshine Health Kosher Cold & Flu Support, and “Nutri-Supreme Research Kosher Cold & Flu Plus with Olive Leaf, Garlic and Oregano Extract); FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339379.htm
Mednoscript St. Petersburg, Russian Federation (2/11). Reviewed Web site mednoscript.com. Unapproved new drugs, misbranded (generic Tamiflu); FDCA 505(a), 503(b)(1), 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339538.htm
Medsys s.a. Gembloux, Belgium (2/5). Inspected 9/17-20/12. Deviations: The firm’s Design Control Procedure does not include the requirements for validation/verification, review, and approval of design changes prior to implementation. It also failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, etc. (Lap Loop Systems); 21 CFR 820.30(i), 820.198(a), 820.90(a), 820.80(b), 820.80(d), 820.70(g)(1), 820.72(a), 820.22, 820.20(b)(3)(i), 820.181(a), 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339965.htm
Oasis Consumer Healthcare, LLC Cleveland, OH (2/11). Reviewed the firm’s marketing of its product Halo on its Web site, www.halogermdefense.com. Unapproved new drug. The product includes a Drug Facts panel with information that corresponds to conditions proposed under the OTC Human Use Tentative Final Monograph for Oral Antiseptic Drug Products (59 FR 6084, Feb. 9, 1994). The product is marketed for intended uses that are not addressed under this rulemaking or any other rulemaking under the OTC Drug Review, etc. (Halo); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339773.htm
Secure Medical Inc. Tempe, AZ (2/11). Reviewed Web sites at www.viamedic.com, www.accessrx.com, and www.AmeriMedixRx.com. Unapproved and misbranded new drugs (Tamiflu 75mg gel tablet); FDCA 505(a), 503(b)(1), 502(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339505.htm
Solta Medical, Inc. Hayward, CA (11/28/12). Inspected 7/12-8/17/12. IRB violations: The IRB failed to include all appropriate elements of informed consent. The firm also did not perform site initiation visits and train the investigators on the ISIS, Serenity, and Janus laser protocols and other study and regulatory requirements, etc. (ISIS Laser, Serenity Skin Rejuvenation System, and Janus Resurfacing Laser); 21 CFR 50.25(b)(1), 812.40, 812.43(c) 54, 812.140(b)(2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm339944.htm
Supplementality LLC (2/11). Reviewed Web site at www.supplementality.com in January. FDA has determined that the Web site offers products for sale that are intended to diagnose, mitigate, prevent, treat or cure the flu virus in people. (Resveratrol (40mg and 250mg), Garlic 90 (500mg), Echinacea, Elderberry, Ashwagandha (aka Indian Ginsing, Winter Cherry) (500mg), and Astragalus Immune System Support (500mg))
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339368.htm
Tan Extreme, Inc. and L.A. Tan, Inc. Lincolnwood, IL (2/8). Inspected 7/27. Unapproved devices, misbranded: (42 Collagen BodyWave); FDCA 501 (f)(1)(B), 502(o)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339959.htm
USPlabs, LLC Dallas, TX (12/4/12). Inspected 2/7-21/12. Misbranded: The products are promoted for conditions that cause them to be an unapproved new drugs (Jack3d, OxyElite Pro, and Super Cissus); FDCA 505(a), 502(f)(1), 21 CFR 111.553, 111.70(e), 111.123(a)(1), 111.75(a)(1)(i)&(2)(ii), 111.105(a), 111.205(b)(1), 111.210(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm339936.htm
Vitamix Vitamins (2/11). FDA and the FTC have reviewed Web sites at www.vitalmaxvitamins.com and www.healthyanswers.com in January. FDA has determined that the firm offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the flu virus, etc. (BodyGuard) FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm339367.htm
Wholistic Herbs, Inc. Dallas, TX (10/5/12). Inspected 12/28/11-1/10/12. GMP violations, adulterated, misbranded, unapproved new drug: The firm did not prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that it manufactures. The firm receives dietary ingredients, grinds, blends, and encapsulates, packages, and labels the finished dietary supplements; but it does not create and maintain any batch records, etc. (dietary supplement products such as At-Ease, Aller-Ban, Stomach Flu, and Morning Calm); FDCA 505(a), 502(f)(1), 21 CFR 111.205(a), 111.255(a), 111.103, 111.70(b-g), 111.75(a)(1)(i), 111.475(b), 111.13(a), 111.553, 111.570, 111.503, 111.535, 111.83
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm339774.htm
