Drugs

7 Observations in Zhejiang Huahai FDA-483

FDA has released the form FDA-483 issued following an 11/12-11/20/2024 inspection at the Zhejiang Huahai Pharmaceutical Co. active pharmaceutical ingredient (API) manufacturing facility in Linhai, Taizhou Zhejiang, China. The seven inspection observations were:

failure of laboratory records to include complete test data derived from all tests;
failure to investigate deviations from analytical test procedures;
failure to adequately conduct laboratory investigations to determine the root cause;
failure to always investigate deviation investigations relating to facility, equipment, and production;
lack of quality unit oversight to ensure the integrity of test data and document management;
master batch production record lacks established time limits and detailed production instructions to ensure the quality of intermediates and APIs are met for individual processing steps and/or total process;
failure to maintain equipment used in the manufacture of intermediates and APIs in a good state of repair to prevent contamination that would alter the safety, identity, strength, quality, and purity of the drug product; and
the procedure for collecting cleaning samples from the manufacturing equipment is deficient.

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