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Latest FDA Warning Letters

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

Golden Caviar Skin Care Irvine, CA (7/13). Reviewed Web site at http://goldencaviarskincare.com/ in April. Misbranded: The Web site promotes products for conditions that cause them to be drugs. For example, for Blood Pressure Support Formula it claims “[H]as been shown to lower blood pressure levels” and “[H]ave been proven to have antihypertensive effects.” The Caviar Lifting & Firming Serum with Zinc, Redness Calming Serum, Blood Pressure Support Formula, Joint Support 4700 MG, and Mood Boost Mood Formula products are offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for their intended purposes, etc. (Blood Pressure Support Formula, COQ-10 30MG, Joint Support 4700 MG, Mood Boost Mood Formula, Alpha Arbutin Cream (Whitening Cream), Bio Whitening, Caviar Lifting & Firming Serum with Zinc, Heal & Conceal, Redness Calming Serum); FDCA 505(a), 502(a)

Sipra Labs Ltd. Hyderabad, India (7/23). Inspected 2/24-3/1/14. GMP deviations, adulterated: The firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods. FDA’s previous inspections of 4/2009 and 9/2011 found that many methods used by the firm to test products had not been verified or validated. Its current inspection found that methods continued to be validated inadequately, and that some methods cited in the last inspection were still not validated. For example, the current inspection documented that only four of the 14 analytical methods identified in the 2011 inspection have since been validated and 10 methods remain unvalidated. The FDA investigator observed that written procedures do not adequately address the need to investigate anomalies, unexpected events, or out-of-trend results, etc. (finished pharmaceuticals and APIs); FDCA 501(a)(2)(B), 21 CFR 211.165(e), 211.192


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