Drugs

CGMP Deviations Seen in Glicerinas Inspection

A 5/8-5/12/2023 FDA inspection at the Glicerinas Industriales drug manufacturing facility in Zapopan, Mexico, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 1/16 Warning Letter says the specific deviations were:

failing to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their certificate of authority; and
failing to document, explain, and investigate any deviation from established procedures.

FDA recommends that Glicerinas retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed the firm on an import alert on 1/16. It noted that Glicerinas had been placed on an earlier import alert and had been issued a Warning Letter on 6/13/2022 for refusing an inspection.

The company was told to correct the deviations promptly and to respond with a list of specific steps it has taken to correct the deviations and prevent their recurrence, with a schedule for completing the work.

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