2011年 6月 8日

The US Food and Drug Administration’s database of publicly available inspection information has officially launched.

The Inspections Database provides information on the compliance status of regulated firms and facilities that must comply with the Food, Drug and Cosmetic Act. Inspection data is classified according to individual firms’ compliance status. Inspection results, from least to most serious, are indicated either as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI).

The database is updated “regularly,” according to the FDA, to reflect changes in compliance status of firms listed.

No doubt some medical device manufacturers and other firms subject to the Food, Drug and Cosmetic Act are less than thrilled that the FDA has begun disclosing this data to the general public. But if the agency is indeed able to keep its Inspections Database up to date—a big if—firms should have little to worry about.