FDA Inspects Hovione's API Manufacturing Plant in Macau
The inspection, carried out by Mr.
Hovione plants have been the object of 16 FDA inspections, with 6 at the
The way inspectors look to the softened water system is probably a good example of the new "FDA Approach". They look to basic aspects like the Design, Operational and Performance Qualification and to the last years Annual Report and concluded that the system has a good performance. But on top of this they expect permanent monitoring of several operational parameters of the system, Municipal Water quality and performance of the Municipal Water systems in order to assure reliability.
About Hovione. Hovione is an international company with 50 years'
experience in Active Pharmaceutical Ingredient development and compliant
manufacture. With four FDA inspected sites in the US,
For more information about Hovione, please visit the Hovione site at
http://www.hovione.com or contact Corporate Communications,
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