Drugs

FDA Sends Akorn Warning Letter

FDA 1/4 sent Akorn a Warning Letter related to a month-long inspection at its Decatur, IL manufacturing facility that was conducted in April and May last year. In disclosing the letter, the company says it will work collaboratively with FDA to resolve all issues cited, and it will respond within the required 15 working days. “The company has full confidence in the quality of the products manufactured at the Decatur facility and expects to continue production at the plant,” it says.

During the ongoing partial government shutdown, FDA employees are not routinely releasing Warning Letters. However, FDA Webview last year obtained a copy of the related FDA-483 from the inspection. Specific observations in the document were:

failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
failing to include in an annual report a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented;
failing to establish an adequate system for cleaning and disinfecting the room and equipment used to produce aseptic conditions;
failing to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management;
failing to submit an NDA-Field Alert Report within three working days of receiving information concerning bacteriological contamination and/or significant chemical, physical, or other change or deterioration in a distributed drug product;
failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance;
failing to examine visually upon receipt and before acceptance of each container or grouping of containers of components for container damage, broken seals, or contamination;
failing to have the written stability program for drug products include reliable, meaningful, and specific test methods;
failing to establish control procedures that monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions; and
failing to examine visually for evidence of deterioration at least once a year reserve samples from representative sample lots or batches of drug product selected by acceptable statistical procedures.

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