FDA Policy/General

CGMP Violations Found in Med-Pharmex Inspection

A 1/17-2/1 FDA inspection at Med-Pharmex, Pomona, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals in the firm’s manufacturing of animal drug products including sterile injectables, oral suspensions, ointments, creams, non-sterile injectables, and non-sterile topical ointments. A 5/17 Warning Letter from the agency’s Los Angeles District Office says that specific violations included:

failing to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failing to exercise appropriate controls over computer related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
deficiency in aseptic processing areas regarding air supply that is filtered through high-efficiency particulate filters under positive pressure;
deficiency in aseptic processing area regarding the system for monitoring environmental conditions;
failing to have an adequate system for cleaning and disinfecting the aseptic processing area; and
failing to have laboratory records that include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays.

The letter says the firm’s responses to the inspection observations were inadequate. It also notes that the company’s Web site contains the FDA logo with a direct link to the agency’s main Web site. “The FDA logo is for the official use of FDA and not for use on private sector materials,” it says. “Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.”

Med-Pharmex was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completion.

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