Drugs

CGMP Violations Found at Xiamen Origin Biotech

A 1/18-20 FDA inspection at Xiamen Origin Biotech, Fujian, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 7/19 Warning Letter. Specific deviations noted in the letter include:

failing to establish, document, and implement an effective system for managing quality;
failing to transfer all quality or regulatory information receive from the API to customers; and
failing to keep buildings used in the manufacture of API in a clean condition.

The letter also says that during the inspection the firm made misleading or deceptive statements and delayed the investigator’s access to accurate and truthful information.

“Based on the nature of the deviations we identified at your firm,” the letter says, “we strongly recommend engaging a consultant qualified to evaluate your operations and assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.”

The company was told to respond with a list of all actions taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion. Due to the inspection findings, the firm’s facilities were placed on Import Alert 5/13.

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