Roberts eliminates backlog of annual reports cited in FDA warning letter.
Executive Summary
ROBERTS ANNUAL REPORT BACKLOG CLEARED FOLLOWING FDA WARNING LETTER that cites the firm for failing to make required reports for approved NDAs. Roberts Pharmaceutical said that it has eliminated the backlog of annual reports that were of concern to FDA. "Your firm has no system for maintaining required records and has failed to maintain required records or make required reports in several instances...regarding approved new drug applications," the Dec. 31 warning letter states.