Drugs

FDA Releases Apitoria Pharma FDA-483

FDA has released the form FDA-483 issued following a 9/23-9/27 inspection at the Apitoria Pharma Private Limited active pharmaceutical ingredient manufacturing facility in Telangana, India. The 10 inspection observations were:

equipment used in the manufacturing of drug substances and intermediates is not of adequate upkeep to facilitate operations for its cleaning and maintenance;
failure to establish adequate manufacturing instructions in the production records for drug substances and intermediates;
failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the particular operations that each employee performs and current good manufacturing practices as they relate to the employee’s functions;
failure of the quality unit to review and approve all appropriate quality-related documents;
the redacted water system design and the water sampling method to ensure the quality of redacted water are not adequate;
failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and active pharmaceutical ingredient batches to meet specifications;
the equipment is not adequately qualified;
the equipment cleaning validation protocol is inadequate;
failure to ensure that new and modified facilities and equipment are qualified; and
failure of the quality unit to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials.

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