Drugs

Sun Gets FDA ‘NAI’ Inspection at Troubled Plant

FDA has classified a recent inspection of Sun Pharmaceutical Industries’ troubled Halol, India plant as “no action indicated (NAI),” meaning the firm appears to have moved past GMP troubles that have been dogging it for years. According to FDA, a June inspection at the plant has been classified as NAI and that no objectionable conditions or practices were found during the inspection or the objectionable conditions found do not justify further regulatory action.

The Sun facility was issued a Warning Letter in 2015 and the company has been working ever since to correct violations. The plant is important to the company because it produces about 15% of its U.S. sales.

The June inspection that was just classified resulted in a five-page Form 483. According to the document, FDA investigators cited the firm for not following procedures that are designed to prevent microbiological contamination of drug products. For example, the form said that the aseptic process validation master plan was not followed during execution of a media fill run. Sun was also cited for not documenting laboratory control mechanisms at the time of performance. For example, the investigators said environmental monitoring of plates showed that in certain instances the primary reviewer performed the plate analysis almost two hours prior to the witness review. And, FDA cited Sun for not validating a process involving air supply, assembly air, and clamp air pressures.

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