Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.


Ambco Electronics Tustin, CA (9/26). Inspected 7/8-7/27. QSR deviations, adulterated: Corrective and preventive action activities and/or results have not been adequately documented. The firm failed to fully investigate and document reported device failures, as required by the Customer Experience Investigation SOP. Also, the finished device acceptance testing and calibration procedure for audiometer model 1000+ lacks specific directions and limits for accuracy and precision, and does not identify the acceptable results or specifications to meet, etc. (Audiometers, Models: 1000 +, 650A, 650AB, and 2500); FDCA 501(h), 21 CFR 820.100(a)&(b), 820.198(c), 820.80(a), 820.184, 820.50, 820.200(a), 820.25(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416625.htm

ANDAPharm Fort Lauderdale FL (8/26). The owner of facility has failed to pay the appropriate facility fee. (active pharmaceutical ingredients); 21 U.S.C. 379j-41to 379j-42
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416663.htm

Hospira Australia Pty, Ltd. Victoria, Australia (9/26). Inspected 2/24-3/1. GMP deviations, adulterated: Several out-of-specification results for the impurity (purged) from the stability studies of multiples batches of (purged) Injection were inadequately investigated. The FDA inspection revealed that in 5/2012, the firm received a notification that visible particles were detected in (purged) injection finished product. No effective corrective action and preventive action plans were implemented to address the recurrent findings of foreign matter, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.192, 211.100(a), 211.42(c)(10)(iv)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416648.htm

Infopia Co., Ltd. Anyang-si, Gyeinggi-do, South Korea (7/10). Inspected 2/17-2/20. QSR deviations, adulterated: The firm failed to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product. It also failed to ensure that when results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, etc. (Easygluco (glucose), Element (glucose), GluNEO (glucose), GluNEO Lite (glucose), Healthpro (glucose), Hemocue HbA1c 501 (hemoglobin), LipidPro (lipid), and LipidPlus (lipid)); FDCA 501(h), 21 CFR 820.100(a), 820.75(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416879.htm

Multimmunity, Inc. Denver, CO (9/25). Reviewed Web site at www.multimmunity.com in July. Unapproved new drug, misbranded: The Web site makes claims that provide evidence that the Multimmunity product is intended for use as a drug. The claims include: “Heart Health…A preventive non-drug approach to heart disease…” and under the heading “Why Take Multimmunity?”: “Concussion Prevention/Recovery,” etc. (Multimmunity); FDCA 403(s)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm417431.htm

Nova Products, Inc. Aston, PA (9/26). Inspected 1/13-2/7 and 3/21. Unapproved new drugs, misbranded: FDA confirmed through laboratory analysis that the firm’s products contain the undeclared active pharmaceutical ingredients sildenafil and tadalafil. FDA’s investigator was refused required access to the complete inventory of all products previously sampled. It regards this refusal as a serious violation because it hinders FDA’s investigators’ ability to thoroughly and completely evaluate the firm’s ability to market and distribute products that do not violate the FDCA, etc. (Xzone 1200, Mojo Risen, Black Ant, African Black Ant, Xzen 1200, Xzen Gold, Xzone Gold, and Xzen Platinum); FDCA 502, 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416696.htm