Drugs

CGMP Violations at Jiangsu Hengrui

A 1/8-1/16 FDA inspection at Jiangsu Hengrui Pharmaceuticals in Lianyungang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says specific violations were:

failure of the firm’s quality unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas.

FDA says the firm’s responses to the inspection observations were inadequate. It acknowledges that Jiangsu is using a consultant to audit its operation and assist it in meeting CGMP.

The agency told Jiangsu 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