Drugs

Liebel-Flarsheim CGMP Violations Cited

A 3/25-4/8 FDA inspection at the Liebel-Flarsheim drug manufacturing facility in Raleigh, NC, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/17 Warning Letter says the specific 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 have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups, and failure to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

FDA says the firm’s responses to the inspection observations were inadequate. It recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements.

Liebel-Flarsheim was told to correct the 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.

The letter says FDA may withhold approval of new applications or supplements listing the firm as a drug manufacturer until any violations are completely addressed and the agency has confirmed compliance with CGMP. It cautions that it may re-inspect to verify that the company has completed corrective actions to address any violations.

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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