For Klinge Chemicals in Glasgow, Scotland, the problem was water quality. Inspectors wrote in Warning Letter 320-11-007 that the API maker lacks procedures for controlling and monitoring its water system.
It's familiar ground for both parties. The letter says that the agency "continues to have concerns" about the system.
"This deficiency was brought to your attention during the last FDA inspection in 2003," the warning states. "Your failure to correct leads us to question your commitment to manufacturing quality APIs. Please explain why your firm did not implement corrective action after the 2003 inspection."