FDA Policy/General

Latest FDA Warning Letters

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

Leiter’s Compounding San Jose, CA (2/29). Inspected 9/15/14-10/7/14. CGMP deviations, adulterated: The facility failed to submit a report to FDA upon initial registration and again in 6/2014, identifying the drug products that it compounded during the previous six-month period. The firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. The facility failed to submit a report to FDA upon initial registration as an outsourcing facility in 1/2014, and again in 6/2014, identifying the drug products that it compounded during the previous six-month period, etc. (drug products); FDCA 503B(a)(10), 503B(b)(2), 501(a)(2)(B), 502(f)(1), 21 CFR 211.113(b), 211.94(c), 211.167(a), 211.111, 211.192
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm492204.htm

Rx Vitamins, Inc. Elmsford, NY (3/17). Inspected 9/21/15-9/28/15. Unapproved, misbranded: The products Chewable Licorice, NaturLo Cholesterol, and Advanced Prostate Formula are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use the firm’s first products safely for their intended purposes. The firm’s “Testost-Rx,” “DB-7,” “The Bone Density Formula,” “NaturLo Cholesterol,” “ThyRx-7,” and “Arth-9” product’s labels are misbranded in that the labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement, etc. FDCA 403(y), 403(q)(1)(A), 403(q)(5)(F), 403(s)(2)(C), 21 CFR 101.36(b)(2)(i)(B), 101.36(b)(2)(i)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491523.htm

Rightway Nutrition Marketing, LLC Bluffdale, UT (3/7). Adulterated: The Supplement Facts panel on the firm’s product “Green Coffee Bean Extract +Energy,” which is labeled and/or offered for sale as a dietary supplement, declares Acacia rigidula Powder as a dietary ingredient. The product is adulterated because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. To the best of FDA’s knowledge, there is no information demonstrating that A. rigidula was lawfully marketed as a dietary ingredient in the U.S. before 10/15/94, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered, etc. (Green Coffee Bean Extract +Energy); FDCA 402(f), 413(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489462.htm

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome