Drugs

CGMP Violations in Voyant Beauty Inspection

An 8/23-9/2/22 FDA inspection at the Accra-Pac drug manufacturing facility, doing business as Voyant Beauty in Elkhart, IN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/20 Warning Letter says specific violations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch was already distributed;
failing to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms; and
failing to conduct, for each batch of drug product, at least one test to verify the identity of each component of a drug product.

The letter reminds the company that it is responsible for the quality of drugs it produces as a contract manufacturer. It acknowledges Voyant’s commitment to cease the production of sulfatrim pediatric suspension at this facility and asks the company to indicate whether it intends to resume manufacturing the drug at the facility in the future.

FDA also notes that some of the products the company manufactures may be regulated as cosmetics and says such products may be considered adulterated if they contain benzene.

Voyant was told to correct any violations promptly and to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.

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