Drugs

Azurity Selling Unapproved Drugs: FDA

A 2/2-3/2/23 FDA inspection at the Azurity Pharmaceuticals drug manufacturing facility in Wilmington, MA, found that the firm manufactures several prescription drug products referred to as FIRST Unit-of-Use kits that are legally considered to be unapproved new drugs. A 9/20 Warning Letter says the inspection also found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs.

The letter says the company’s FIRST Lansoprazole, FIRST Pantoprazole, FIRST Metronidazole, and FIRST Mouthwash BLM are defined as drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Since the products are not generally recognized as safe and effective for their labeled uses, FDA says, they are new drugs and cannot be legally marketed without an FDA-approved application.

FDA says the specific CGMP violations were:

failure 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 has already been distributed; and
failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

“Your firm’s quality systems are inadequate,” FDA says. The agency recommends that Azurity engage a qualified consultant to assist it in meeting CGMP requirements.

The firm was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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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