Drugs

Jiangsu Hengrui Inspection Nets 8-item 483

A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, resulted in an eight-observation Form FDA-483. Agency inspectors found that the firm’s procedures designed to prevent microbiological contamination of drug products did not include adequate validation of the aseptic and sterilization process. The inspection also found that the company’s container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. And the agency cited Jiangsu Hengrui over its equipment and utensils not being cleaned appropriately to prevent contamination. Other observations include:

The quality control unit lacks the responsibility to approve all procedures or specifications impacting the identity, strength, quality and purity of drug products.
Records associated with drug product production were not made readily available for inspection.
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are made only by authorized personnel.
Buildings used in storing drug products are not maintained in a good state of repair.
Washing and toilet facilities lacked hot and cold water.

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