FDA uncovers data-integrity concerns at Kyowa Hakko in Japan

By PharmaCompass

2018-08-30

Impressions: 232 Article

While patients and regulators across the world deal with the consequences linked to the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen, as a contaminant in a commonly used blood pressure medicine, valsartan, the inability of multiple inspections by European, American and Chinese regulators to uncover the problem has brought the spotlight back on how regulatory oversight of manufacturing facilities can be improved.

Last week, the FDA posted a warning letter issued to Kyowa Hakko, a leading manufacturer of amino acids and other active pharmaceutical ingredients (APIs) in Japan and recommended that the Japanese firm implement data integrity remediation measures.

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