Some companies now tout passing plant inspection

Until recently, getting a clean plant inspection by a top regulator would pass unnoticed, something companies expected as part of their manufacturing plans. Most of the news of FDA inspections is tied to warning letters, import alerts and Form 483s. There has been a load of that kind of news recently, particularly tied to plants in India that have been cited or banned for serious manufacturing lapses. Now, some companies see virtue in letting the industry know when they pass an inspection. Portugal-based Hovione this week said its plant in Loures, Portugal, had passed a GMP and postmarket approval inspection by the FDA. The company even named the inspector who handled the 5-day inspection. Hovione's CEO Guy Villax said, "Doing well in the eyes of an FDA inspector is always a motive of satisfaction." The company went on to say that its 5 plants were the object of 12 inspections in the last 18 months, including 5 by the FDA in Portugal, Ireland, Macau and New Jersey, although it mentions that only four of those ended with no Form 483. It also said it passed inspections by regulators from Ireland, Korea and China. Release | More