Drugs

Cosmetic Solutions CGMP, Unapproved Drug Violations

A 9/12-9/21/2023 FDA inspection at the Cosmetic Solutions drug manufacturing facility in Boca Raton, FL, identified current good manufacturing practice (CGMP) regulation and unapproved new drug violations in the firm’s manufacturing of finished drugs. A just-released 5/31 Warning Letter says specific CGMP violations were:

failure to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such procedures; and
failure to establish adequate written procedures for production and process control designed to assure that drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of the written production and process control procedures.

The firm’s responses to the CGMP observations were inadequate, FDA says. The letter says its review of labeling and the Web site for redacted products indicates that they are legally considered to be drugs and are not generally recognized as safe and effective for their use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Thus, it says, the products require FDA approval and there is no approved application in effect for them.

FDA recommends that Cosmetic Solutions engage a qualified consultant to assist it in meeting CGMP requirements. The company was told to correct violations promptly and to respond with a list of specific actions it has taken to address 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