FDA inspects Hovione's API manufacturing plant in Macau

Hovione's API plant in Macau has passed a pre-approval inspection by the US FDA.

Jorge Pastilha, general manager of the plant, said the inspection focused on the execution side rather than the documentation system.

"The inspectors wanted to know how we did in specific situations rather than how we should do in hypothetical situations. I am glad that we continue to do well in compliance issues," he said.

Hovione plants have been inspected 16 times by the FDA, with six inspections at the Macau site since it started operation in 1986. The objective of this current inspection was to evaluate how operators and analysts follow the guidelines and internal procedures day-to-day. Special emphasis was given to preventive and corrective actions implementation and follow-up, and water systems operation.

The Macau plant employs 120 people and produces both Hovione catalogue generic products and commercial APIs and has been increasingly used by Hovione customers to produce clinical trial quantities of compounds for Phase I and II testing. The facility is responsible for a third of Hovione's total production and exports to the US, EU, and Australia.