Drugs

7 Observations in Wells Pharmacy Inspection

FDA has released the FDA-483 issued following a 12/1/20-1/28/21 agency inspection at Wells Pharmacy, a Dyersburg, TN, outsourcing facility. The inspection’s seven observations were:

failing to thoroughly review the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations (repeat observation from 2018);
failing to maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
the quality control unit lacks the responsibility to approve and reject all procedures or specifications affecting the identity, strength, quality, and purity of drug products (repeat observation from 2018);
company records are deficient in that they do not include the findings of the investigation and follow-up;
individuals responsible for supervising the manufacture, processing, packing, and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess; and
the facility compounds drugs that are essentially a copy of one or more approved drugs within the meaning of the law.

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