Drugs

Samson Pharmaceuticals Inspection Finds CGMP Issues

A 1/24-2/9/18 FDA inspection at Samson Pharmaceuticals’ drug manufacturing facility in Commerce, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 12/13/18 Warning Letter says the violations were:

failing to perform aseptic processing operations within specifically defined areas that have floors, walls, and ceilings of smooth hard surfaces that are easily cleanable, and failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic processes;
failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods;
failing to ensure the identity of components, including active ingredients and excipients from various suppliers; and
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.

The letter says FDA strongly recommends that Samson engage a qualified consultant to assist it in meeting CGMP requirements. The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion of the corrections.

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