Drugs

CGMP, Other Violations at PureChemPros

An 11/17-11/22/2022 FDA inspection at the PureChemPros drug manufacturing facility in Tempe, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, and other violations. A 9/1 Warning Letter says the firm’s 35% food-grade hydrogen peroxide and 3% food-grade hydrogen peroxide products are unapproved new drugs illegally introduced or delivered for introduction into interstate commerce. The letter says specific CGMP violations were:

failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the component supplier’s test analyses at appropriate intervals; and
failing to assure that the drug product bears an expiration date that is supported by appropriate stability testing.

The letter also describes unapproved new drug and misbranding violations found during the inspection.

“In response to this letter,” FDA says, “confirm whether you intend to continue manufacturing any drugs at this facility or any other facility in the future. If you plan to continue CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance.” The agency recommends that PureChemPros retain a qualified consultant to perform an audit of the firm’s entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the firm’s corrective and preventive actions before it pursues resolution of its compliance status.

PureChemPros was told to promptly correct the violations and to respond with a list of specific steps it has taken to correct 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