Biocon facility in Malaysia found to have issues once again by the FDA

A recent FDA inspection of a Biocon manufacturing facility in Malaysia has revealed more issues relating to cleanliness.

The regulator inspected Biocon’s manufacturing facility in Iskandar Puteri, located near Singapore, between July 10 and July 20. The site manufactures sterile drugs, including insulin glargine, a biosimilar version of Sanofi’s Lantus.

The 10-page report cites cleaning deficiencies for tools and problems related to airflow in aseptic areas. It also reported a lack of integrity testing, which is done to ensure there are no defects, such as tears or pinholes, before the manufacturing of sterile drug products.

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来源: EndPoints

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