Biocon Malaysia insulin aspart plant hit with 6 observations by US FDA

Six months after getting a VAI status from the US Food & Drug Administration for its insulin glargine manufacturing facility in Malaysia, Biocon — India’s largest biopharmaceuticals company — said the US FDA issued six observations after pre-approval inspections at its insulin aspart plant in that country.

Insulin glargine is a long-acting insulin-substitute, while insulin aspart is a fast-acting substitute. The two are often administered together for optimal effect.

US FDA approval is a must if the company has to export insulin aspart to the US market.

Biocon said the observations have been issued across drug substance, drug product and devices facilities

“We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the US FDA in the stipulated time.

“We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of Quality and Compliance,” it added.

In February this year, the glargine plant in Biocon’s Malaysian facility was given a ‘voluntary action indicated’ classification after three observations were issued on inspection.

The FDA classifies each plant under three categories after each inspection – NAI or no action indicated, VAI or voluntary action indicated and OAI or official action indicated.

Voluntary Action Indicated (VAI) means the inspectors found objectionable conditions or practices but the agency is not prepared to take or recommend any administrative or regulatory action.