Drugs

CGMP Violations in GC America Inspection

An 11/3-11/ 7/2025 FDA inspection at the GC America drug manufacturing facility in Alsip, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were:

failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality;
failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to test an adequate number of batches of each drug product to determine appropriate storage conditions and expiration dates; and
failure to establish adequate written responsibilities and procedures applicable to the quality control unit.

FDA recommends that GC America engage a qualified consultant to assist it in meeting CGMP requirements.

The company 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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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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