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.

Fagron Compounding Services Wichita, KS (11/28): FDA inspected the outsourcing drug facility in 2016 and cited serious deficiencies in its practices for producing sterile drug products. For example, the firm failed to establish and follow adequate written procedures applicable to the quality control unit. It also did not have appropriate laboratory determinations of satisfactory conformance to final specifications for each drug product.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587714.htm

RC Outsourcing, Lowellville, OH (11/28): FDA inspected the drug outsourcing facility in March and noted serious deficiencies in its practices for producing compounded sterile drug products. For example, the firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products. The firm also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587833.htm

Seindni Co. Seoul, Korea (12/5): FDA inspected the firm in May and cited GMP violations for finished pharmaceuticals. For example, the firm failed to establish a quality control unit and procedures to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. The letter recommended that the firm retain a GMP consultant to correct its violations.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588215.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