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.

Dong Yuan Technology Co. Shandong Province, China (3/18): FDA inspected the firm 9/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish and follow laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards. Dong Yuan also failed to establish adequate written procedures for production and process controls. And, it failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634646.htm

Inopak Ltd. Ringwood, NJ (2/21): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Inopak also failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing. And it failed to establish adequate written responsibilities and procedures applicable to the quality control unit.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm634625.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