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.

China Resources Zizhu Pharmaceutical Co., Ltd. Beijing, China (4/24): FDA inspected the firm and cited significant GMP deviations associated with its active pharmaceutical ingredients manufacturing. For example, the inspection found that the firm’s laboratory systems lacked controls to prevent deletions from and alterations to electronic raw data. A review of the firm’s audit trail data revealed that analysts manipulated the date/time settings on its high performance liquid chromatography systems. Additionally, the inspection found that the firm failed to maintain complete data for all laboratory analyses, and it relied on incomplete information to determine whether drugs met established specifications.

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm563067.htm

Sewaren Innovative Pharmaceutical Packaging Avenel, NJ (5/22): FDA inspected the firm 6/2016 and cited it for serious deficiencies in its compounding practices for producing sterile drug products. For example, the firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products it produced. The inspection also noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm563170.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