Drugs

CGMP Violations at India’s Srikem Laboratories

A 12/14-12/18/15 FDA inspection at Srikem Laboratories, Mumbai, India, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients, according to an 11/8 Warning Letter. Specific deviations included:

failing to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards; and
failing to follow and document laboratory controls at the time of performance.

The letter says the company’s responses were inadequate. It also says the firm’s quality system “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” FDA recommends that the firm retain a qualified consultant to assist in its remediation. Srikem is to submit a comprehensive investigation into the extent of the inaccuracies in data records and reporting, a current risk assessment of the potential effects of the observed failures on drug quality, and a management strategy including details of its global corrective action and preventive action plan.

The agency placed the firm on an Import Alert 7/6. Srikem was told to respond with a list of actions it has taken since the inspection to correct the deviations and prevent their occurrence, with 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