Warning Letter to UK Devicemaker Provides 483 Response Breakdown

An FDA warning letter issued to British devicemaker Central Surgical offers an unusually detailed look at why the company’s Form 483 response was deemed insufficient. The Dec. 27, 2012, letter notes four quality system regulation violations found during an Aug. 13-14, 2012, inspection of the company’s London facilities. To start, Central Surgical had no records to show that results of its sterilization process, which were not verified or tested, had been thoroughly validated.
Devices & Diagnostics Letter