Drugs

9 Items on Bentley Laboratories FDA-483

FDA has released the form FDA-483 with nine observations from a 3/16-3/27 inspection at the Bentley Laboratories over-the-counter drug manufacturing facility in Edison, NJ. The specific observations were:

reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals;
failure of testing and release of drug products for distribution to include appropriate laboratory determination of satisfactory conformance to the final specifications, identity, and strength of each active ingredient before release;
failure to thoroughly review any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
failure to verify the suitability of all testing methods under actual conditions of use;
failure of the written stability program for drug products to include reliable, meaningful, and specific test methods;
failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are initiated only by authorized personnel;
failure to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality they are purported or represented to possess;
failure to establish and follow written procedures for the cleaning and maintenance of equipment, including utensils used in the manufacture, processing, packing, or holding of a drug product; and
failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

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