Drugs

Zhejiang Huahai FDA-483 Released

FDA has released the form FDA-483 with seven observations from a 1/16-1/24 inspection at Zhejiang Huahai Pharmaceutical Co. in Linhai, Zhejiang, China. The inspection observations were:

failure to clean equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of a drug product;
failure to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to have adequate validation of the sterilization process;
failure to have written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
the quality control unit lacks the authority to review production records to assure that no errors have occurred.

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

Read more

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