Drugs

Data Integity, CGMP Issues at Zhejiang Hisoar

An 8/10/15-8/13/15 FDA inspection at Zhejiang Hisoar Pharmaceutical Co., Taizhou City, China, found current good manufacturing practice and data integrity violations in the firm’s manufacturing of active pharmaceutical ingredients, according to an 8/11 Warning Letter. Specific violations included:

failing to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards;
failing to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data; and
failing to record activities at the time they are performed.

The letter also says that some records investigators requested during the inspection were not available for review, and that the firm’s quality control system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It acknowledges that the firm is using a consultant to audit its operation and assist in meeting FDA requirements.

The company was placed in a 1/20 Import Alert. It was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, along 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