Drugs

Outsourcing Facility Producing Illegal Drugs: FDA

A 7/27-9/3/21 FDA inspection at Hybrid Pharma, a Deerfield Beach, FL, outsourcing facility, determined that drug products produced there failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to be exempt from certain provisions of the law. A 6/7 Warning Letter says the inspection also found serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk.

The letter details ways in which Hybrid did not meet the conditions of Section 503B. It also lists these current good manufacturing practice (CGMP) regulation violations:

failing 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 was already distributed;
failing to establish the accuracy, sensitivity, specificity, and reproducibility of test methods; and
failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The letter further states that Hybrid does not have any FDA-approved application on file for drug products that it compounds and that it compounds drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Finally, Hybrid failed to submit required reports to FDA identifying the drug products that were compounded during previous six-month periods.

The agency says it reviewed the pharmacy’s response to the FDA-483 and could not fully evaluate some of its corrective actions due to a lack of adequate supporting documentation.

Hybrid was told to take prompt action to correct the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with related documentation 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