The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.
The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA's average response, according to letters released by a Freedom of Information Act request from Reuters.
Since the FDA's December 2006 warning letter to NECC, both sides have come under intense scrutiny. State and federal regulators, including the FDA, are being asked why they didn't move sooner against NECC, given a long history of concerns about the family-owned pharmacy's operations.
Source: Reuters. Read full article. (link)