Drugs

CGMP Violations at Yahon Enterprise

A 12/15-12/23/2023 FDA inspection at the Yahon Enterprise Co., Ltd. drug manufacturing facility in Trang Bom District, Vietnam, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/5 Warning Letter says specific violations were:

failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failure to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality;
failure to assure that the drug product bore an expiration date that was supported by appropriate stability testing; and
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.

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

Yahon was told to correct any 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.

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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