Klinge Chemicals in Glasgow received FDA coal in its stocking by way of a December 21, 2010, warning letter. The rebuke refers to a June inspection of Klinge's API facility, but this story goes back much further in time.
A chief concern is water quality. FDA inspectors write that the company lacks such fundamentals as procedures for controlling and monitoring its water system; Klinge hasn't shown that it's in control of microbial levels.
The warning informs managing director Michael Klinge that his post-inspection response lacks details on system maintenance and monitoring, as well as alert and action limits for microbial contamination. And here inspectors gives their first hint of the history with Klinge, noting that they "continue to have concerns" about the water system.
They lower the boom after acknowledging that Klinge is in process with the second stage of the system's qualification. "This deficiency was brought to your attention during the last FDA inspection in 2003," the warning letter 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."
- see Warning Letter 320-11-007