Drugs

CGMP Violations at Sircle Laboratories

A 4/13-26 FDA inspection at Sircle Laboratories, a Madison, MS, drug manufacturing facility, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/21 Warning Letter says specific 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 establish and follow adequate written procedures describing the handling of all written and oral complaints about a drug product; and
failing to establish and follow written procedures designed to assure that correct labels, labeling, and packaging are used for drug products.

The letter notes that similar CGMP observations were made in 2015 and 2019 inspections. “These repeated violations demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs,” FDA says. “You should immediately and comprehensively assess all of your firm’s manufacturing operations to ensure that systems, processes, and ultimately products conform to FDA requirements.”

The letter also reminds the company that it is responsible for the quality of drugs produced for it by contract manufacturers.

Sircle was told to promptly correct any violations and to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrective actions.

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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