The five day inspection, carried out earlier this month, assessed the control and quality system in place at the facility, which makes active pharmaceutical ingredients (API), generics and bulk formulated products on a contractual basis.
No deviations or Form 483s were issued by the US regulatory agency during the inspection, which covered five abbreviated new drug applications (ANDAs) and one NDA.
FDA Inspector of Cincinnati District Mark Parmon, who oversaw the assessment, said he was happy with what he had seen and commended Hovione’s good manufacturing practice (GMP) System and knowledge of its team members.
Hovione’s compliance director, Luisa Paulo, said that: “The inspection focused on the documentation system, especially on how we record and manage OOS, deviations, change control, batch production records and analytical procedures.”
The Loures site, which has been the subject of 10 FDA inspections since 1982, employs a staff of 500 making products for some of the most heavily regulated pharmaceutical markets worldwide.
Hovione’s manufacturing compliance team has had a successful 2009, with pre-approval for Loures being just the latest regulatory achievement.
In June, the firm’s manufacturing facility in Macau, China also passed FDA pre-approval assessment, although on this occasion one Form 483 detailing five points was issued, details of which were not disclosed.
