FDA Policy/General

Latest FDA Warning Letters

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

Miami Fat Supply, Inc. Groveland, FL (3/17). Inspected 10/13-14/15. QSR deviations, adulterated: The firm failed to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures. Although not listed on the FDA Form 483, further review by FDA’s Compliance Branch revealed a failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. For example, the firm has not conducted and/or documented design and development planning, design inputs, design outputs, design review, design verification, design validation, and/or design transfer activities for the Red Head 2, in accordance with its design control procedure, etc. (Red Head, Red Head 2, and the Jordy Connection System) FDCA 501(h), 501(f)(1)(B), 502(o), 21 CFR 820.75(a), 820.30(a)(i), 820.50(a)(1), 820.80(e), 820.100(a)&(b), 820.198, 820.22, 803.17.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495019.htm

Pikeville Medical Center, Inc., IRB Pikeville, KY (3/1). Inspected 8/17/21/15. IRB violations: The IRB failed to prepare, maintain, and follow required written procedures governing the functions and operations of the IRB. For nine IRB meetings, the meeting minutes did not adequately document the vote on actions taken by the IRB, including the number of members voting for, against, and abstaining. The IRB reviewed FDA-regulated research on 1/24/12, without a majority of members present. It failed to conduct continuing review of research at intervals of not less than once per year, etc. (drug study); 21 CFR 56.108(a)&(b)&(c), 21 CFR 56.115(a)(6), 56.115(a)(2), 56.109(f)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm494229.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