Drugs

CGMP Violations in Health Specialty Inspection

An FDA 11/27-11/30/2023 inspection at Cohere Beauty’s Health Specialty drug manufacturing facility in Santa Fe Springs, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/15 Warning Letter says the specific violations were:

failure to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess; and
failure of the firm’s quality control unit to exercise its responsibilities to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

“Your inspectional history and significant findings in this letter indicate that your quality unit is not fully exercising its authorities and/or responsibilities,” the letter says. It notes that similar violations were cited in a 12/2022 inspection and the company proposed specific remediation for the observations in its response and a regulatory meeting with the agency. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency acknowledges the company’s commitment to cease production of drugs at this facility. If Cohere Beauty decides to resume production of drugs, it says, it should engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Cohere was told to correct any violations promptly and to respond with a list of specific actions 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’

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

Read more

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