Drugs

FDA Releases 2 Galaxy Surfactants FDA-483s

FDA has released the FDA-483s issued following an agency 3/26-3/30 inspection at one Galaxy Surfactants manufacturing facility in Tarapur, India, and a 3/19-3/23 inspection at a second manufacturing facility in the same city. Observations from the first report were:

responsibilities and procedures applicable to the quality control unit are not in writing and fully followed;
failing to adequately validate the analytical method for stability studies of an active pharmaceutical ingredient to support the intended commercialization period and expiry;
failing to place on stability at least one batch per year of manufactured active pharmaceutical ingredients and to test at least annually to confirm the stability characteristics of the ingredients, appropriate storage conditions, and confirm the expiry dates;
failing to provide good manufacturing practice training to employees at the particular operations that the employee performs and good manufacturing practice as it relates to the employees’ functions;
failing to establish an appropriate equipment cleaning procedure to assure an adequate cleaning of equipment and its subsequent release for use in the manufacture of intermediates and active pharmaceutical ingredients;
· failing to conduct appropriate qualification of critical equipment;
failing to use water that is suitable for manufacturing active pharmaceutical ingredients;
failing to ensure product quality uniformity from batch to batch such that the batch manufacturing records do not conform to the master formula record; and
the APQR (annual product quality review) procedure is deficient.

Inspection observations from the second report were:

failing to provide appropriate good manufacturing practice and position specific training to personnel for the particular operations that each employee performs as it relates to the employee’s function; and
failing to validate the analytical methods required for the trace analysis of active pharmaceutical ingredient residue as part of the cleaning validation program.

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