FDANews
The QMN Weekly Bulletin

Pega Responds to First Warning, Viewing Letter as Wake-Up Call

Dec. 24, 2010
Handling an FDA inspection is nothing new to Pega Medical, but dealing with its first warning letter has been a wake-up call for the Canadian company, its quality manager says. The letter stems from a March inspection of Pega’s Laval, Quebec, facility.

As it has in past inspections, the company wasted no time responding to the observations and correcting them, Enrique Garcia, Pega’s quality manager, said. But this time, it got a warning letter. As soon as the letter arrived, Pega held management and employee meetings to resolve the issues.

The FDA considers Pega’s response to the inspection inadequate because it didn’t include supporting documentation or evidence that the corrective action had been implemented.
The GMP Letter