Drugs

FDA Releases 39-Page Lupin FDA-483

FDA has released the 39-page FDA-483 containing 13 detailed observations issued following a 9/10-11/5/2020 inspection at Novel Laboratories, doing business as Lupin, Somerset, NJ. The inspection observations were:

failing to clean and sanitize at appropriate intervals equipment and utensils to prevent malfunctions and contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed;
failing to follow the written stability program;
failing to establish the accuracy and sensitivity of test methods;
failing to provide the quality control unit responsibility to approve or reject all procedures or specifications affecting the identity, strength, quality, and purity of drug products;
failing to establish and follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
failing to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failing to maintain in a good state of repair buildings used in the manufacturing, processing, packing, or holding of a drug product;
separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations;
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
failing of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to follow written procedures for evaluations done at least [redacted] and including provisions for a review of complaints, recalls, returned, or salvaged drug products, and investigations conducted for each drug product; and
employees engaged in the manufacture, processing, and packaging of a drug product lack the training required to perform their assigned function.

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