Drugs

4 Repeat CGMP Violations at Canada’s Innocore

A 4/22-4/25 FDA inspection at the Tranzonic Innocore Sales & Marketing drug manufacturing facility in Woodstock, Ontario, Canada, found four repeat Current Good Manufacturing Practice (CGMP) violations in the firm’s production of finished drugs. A 10/16 Warning Letter says the specific violations were:

failure to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release, and failure to conduct for each batch of drug product appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms;
failure to conduct at least one test to verify the identity of each component of a drug product;
failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products; and
failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter states that the four CGMP observations are similar to those identified during a 6/2019 inspection, for which the company proposed specific remedial actions. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency recommended that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Innocore was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with 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