Drugs

CGMP Violations at Mexico’s Betone SA de CV

An 11/6-11/10/2023 FDA inspection at the Betone SA de CV drug manufacturing facility in Zapopan, Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/21 Warning Letter says specific violations were:

failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure to formulate batches of drug product with the intent to provide not less than 100% of the labeled or established amount of active ingredient;
failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals; and
failure to assure that the drug product bore an expiration date that was supported by appropriate stability testing.

FDA says the firm’s quality systems are inadequate and recommends that it retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed Betone on an Import Alert on 3/11.

The letter tells Betone to correct any violations promptly and to respond with a list of specific steps it has taken to address the 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’

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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