Drugs

Divi’s Laboratories Inspection Observations

FDA has released the FDA-483 issued following a 9/11-9/19 inspection at Divi’s Laboratories, Andhra Pradesh, India, an active pharmaceutical ingredient (API) manufacturer. Specific observations listed were:

failing to test individual batches of final API for conformity with all appropriate specifications such as purity, strength, and identity;
failing to thoroughly investigate laboratory failures;
review of analytical incident/excursion investigations per the company’s atypical or out-of-trend-results procedure showed instances in which samples injection sequence was completed but results were not calculated and/or compared to specifications to ensure OOS results were not obtained and sample result screening is not occurring prior to invalidating the run for system suitability or chromatograph issues;
failing to validate the manufacturing cleaning length of time in situations that are redacted from the form;
failing to have adequate specified cleaning instructions for the major equipment in the pharma block; and
failing to record contemporaneously batch records at the completion of an operation.

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