Drugs

Repeat CGMP Violations at Guangxi Yulin

A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found repeated significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/30 Warning Letter says the 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 establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failure to establish and follow an adequate written testing program designed to assess the drug product stability characteristics; and
failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records.

The letter says similar violations were cited following a 2016 inspection. “You proposed specific remediation for these observations in your response,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency placed all of Guangxi Yulin’s drugs and drug products on a 9/26 Import Alert.

The company 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.

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