Czech, German Device Companies Among Recent Recipients of FDA Warning Letters

The Food and Drug Administration’s most recent warning letters included warnings to companies in the Czech Republic, Germany, and China, reflecting the agency’s increasing inspectional presence overseas.

For example, in a letter posted to FDA’s website March 12, the agency cautioned Czech company Linet Spol. S.r.o. about its inadequate reporting system for its AC-powered adjustable hospital beds (Eleganza 3, MultiCare, and Eleganza EZ).

“After reviewing your firm’s procedure, we conclude that it fails to establish internal systems that provide for timely and effective identification, communication and evaluation of events that may be subject to the MDR requirements,” Steven D. Silverman, ...