FDA inspects Hovione's API manufacturing plant in Macau.

Hovione's API plant in Macau has just successfully passed a pre-approval inspection by FDA. The inspection, carried out the investigator of New York District office in Buffalo and a Chemist from California District started on 22 Jun 2009 and concluded on the 24 Jun 2009. A Form 483 with five points was issued. The inspection was focused on the execution side rather than the documentation system. Inspectors wanted to know 'how the company did in specific situations' rather than 'how it should do in hypothetical situations'. The obvious objective of this inspection was to evaluate how the 'guidelines and internal procedures' are followed on the day-to-day activity by operators and …