FDA Policy/General

Latest FDA Warning Letters

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

Option Care Enterprises, Inc. Everett, WA (9/7). FDA investigators inspected the drug compounding operation and observed deficiencies in its practices for producing sterile drug products. For example, the inspection noted that the firm uses a non-sterile product to clean the ISO 5 area. Furthermore, a technician was observed touching the inner liner of a waste receptacle and a metal cart and then performing aseptic operations in the ISO 5 hood without first disinfecting her gloves.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521013.htm

Jeffreys Drug Store Canonsburg, PA (8/25). FDA investigators inspected the drug compounding operation and noted the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. The firm was also cited for producing domperidone products, which is not included in a United States Pharmacopeia or National Formulary monograph. Additionally, investigators observed serious deficiencies in the firm’s practices for producing sterile drug products. For example, the inspection observed that the firm did not use a sporicidal agent as part of the disinfection program for the aseptic processing areas.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520399.htm

Sarkli/Repechage, Ltd. Secaucus, NJ (8/18). FDA reviewed the firm’s Web site and determined that claims made for marketed cosmetics make the products unapproved new drugs. The claims suggest the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or they affect the structure or any function of the human body. Affected products include Hydra 4 Red-Out Calming Cleanser, Hydra 4 Red-Out Serum, and Biolight Brightening Daytime Protection Cream.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520655.htm

ZO Skin Health Group, LLC Beverly Hills, CA (8/29). FDA reviewed the firm’s Web site and determined that claims made for marketed cosmetics make the products unapproved new drugs. The claims suggest the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or they affect the structure or any function of the human body. Cited products include Ossential Growth Factor Serum Plus, Ossential Daily Power Defense, and Ossential C-Bright Serum 10% Vitamin C.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521019.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