Drugs

CGMP Deviations at Proquimes SA Productos Quimicos Especializados

FDA says its inspection of records supplied at the agency’s request by Proquimes SA Productos Quimicos Especializados, a registered manufacturer of active pharmaceutical ingredients (API) located in Cali, Colombia, identified significant deviations from current good manufacturing practice (CGMP) for APIs. A 4/5 Warning Letter says specific deviations were:

failing to demonstrate that the manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes;
failing to adequately perform qualification of critical equipment and ancillary systems;
failing to adequately validate written procedures for the cleaning and maintenance of equipment; and
failing to test the identity of each batch of incoming production material.

FDA says it strongly recommends that the firm engage a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and assist it in meeting CGMP requirements.

The agency also says it placed all drugs manufactured by the company on an import alert 12/3/20 and told it to respond with a list of specific steps taken to correct the deviations and prevent their recurrence, with a schedule for completing 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