Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
A2Z Industries, LLC Sherman Oaks, CA (2/9). Inspected 4/17-22/14. Misbranded: The firm’s product labels and Web site at http://vitallabsusa.com make claims which cause them to be unapproved new drugs. These products are represented as dietary supplements on their labels; but the substances listed as dietary ingredients on the labels of EPI 2A3A and Halo-V are synthetic steroids-2a, 3a-epithio- 17a-methyletioallocholanol and 4-chloro-17a-methyl-androst-1, 4-diene-3, 17b-diol, respectively are not dietary ingredients. The Protex product is a drug because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, etc. (Halo-V, Protex, EPI 2A3A); FDCA 505(a), 502(f)(1), 403(y), 403(s)(2)(C), 403(q)(5)(F), 403(q)(1)(A), 403(e)(1)&(2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433809.htm
Carrington Oradell, NJ (1/13). In April FDA reviewed the product label for Carrington Farms Coconut Oil (54 fl oz) and reviewed labeling on the firm’s Web site at http://carringtonfarms.com/ in 8/2014. Misbranded: FDA has determined that the firm takes orders there for the product Carrington Farms Coconut Oil, which both the product label and the Web site labeling promote for conditions that cause the product to be a “drug.” For example, on the Web site it states: “Coconut Oil also has been known to: kill bacteria, ease acid reflux ... lower incidence of hemorrhoids ... soothes ear aches . . . reduces joint and muscle inflammation,” etc. (Coconut Oil); FDCA 403(r)(1), 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433444.htm
Teneo Institutional Review Board Tulsa, OK (11/10/09). Inspected 3/12-18/09. Violations: The Teneo IRB failed to prepare and maintain adequate documentation of IRB activities. The Teneo Minutes from Teneo for the Teneo IRB meeting held on July 8, 2008 fail to show that the Teneo IRB discussed pediatric consent forms and the hiring of pediatric specialists. Sections of the protocol and informed consent are inconsistent related to the participation of children in the study (purged), etc. (investigational study); 21 CFR § 56.115(a)(1) and (2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm191450.htm
Topspins, Inc. Ann Arbor, MI (11/6/14). Inspected 8/5-15/14. QSR deviations, adulterated, misbranded: The firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. It also failed to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The firm did not notify the agency of its intent to introduce the device into commercial distribution in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), etc. (Smart Set intravenous tubing sets); FDCA 501(h), 501(f)(1)(B), 502(o), 21 CFR 820.30, 820.90(b)(1), 820.50, 820.198(a), 820.250(b), 820.100(a).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433532.htm
Verichem Laboratories Inc. Providence, RI (2/4). Inspected 10/14-11/14/14. QSR deviations, adulterated: The firm failed to establish and maintain procedures for validating device design. It also failed to adequately maintain device master records. The 2012 Design Input Plan, Design Output Plan and Design Review for the BR2 Bilirubin Calibrator were not documented until October 2014, more than two years after the design of the product, etc. (clinical chemistry reference materials for in vitro diagnostic use: calibrators and calibration verifiers); FDCA 501(h), 21 CFR 820.30(g), 820.181, 820.40, 820.70(g), 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm
