Drugs

8 Observations in Novo Nordisk FDA-483

FDA has released the form FDA-483 issued following a 3/15-3/25 inspection at a Novo Nordisk drug substance manufacturing site in Kalundborg Sjalland, Denmark. The eight inspection observations were:

the routine sample volume that is used to test for appropriate standards of quality and purity of the redacted water for drug substance manufacturing is insufficient to be representative of the water system capacity;
insufficient information has been provided to demonstrate that the water used for drug substance purification is adequately controlled for total microbial counts and objectionable organisms in water systems;
drug substance manufacturing and processing unit operations that have been observed to be performed for drug substances at the company drug substance manufacturing facility are not included in the submission to the agency for review;
master production and control records lack complete manufacturing and control instructions;
the validation of the drug substance manufacturing process, including a full description of the validation data for critical process parameters and in-process controls in support of routine production, has not been appropriately documented;
written procedures used in the manufacturing, processing, or packing that are designed to assure identity, strength, quality, and purity of the drug substance are inadequate;
the responsibilities and procedures applicable to the quality control unit are not fully followed; and
laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that production cultures conform to appropriate standards of identity, strength, quality, and purity.

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