Drugs

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, Columbia, MD (7/20): FDA inspected the firm in June and cited serious deficiencies with its sterile drug production. The agency noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions. For example, an investigator observed that the firm uses non-sterile wipes and used a non-sterile disinfectant as part of its disinfection program for the aseptic processing areas.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm568132.htm

Sage Products, Cary, IL (7/17): FDA inspected the firm 9/2016 and cited it for GMP violations with its finished pharmaceuticals. For example, the firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. The firm also failed to establish scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards. Additionally, the firm failed to clean, maintain, and, sanitize or sterilize equipment and utensils at appropriate intervals to prevent malfunction or contamination.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm568120.htm

Whitehall/Division of Acorn Engineering Co.,City of Industry, CA (7/12): FDA inspected the firm in March and cited it for GMP deviations associated with its manufacture of whirlpool immersion hydro therapy and dry heat therapy devices. For example, the firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. It also failed to investigate the possible failure of a device to meet any of its specifications. Additionally, it was cited for failing to establish a design history file.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm567734.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