Impact Instrumentation Gets Warning for GMP Deviations

November 26, 2010
Impact Instrumentation received a warning letter after an FDA inspection found its complaint-handling procedure does not require investigations into possible device failures. For example, the West Caldwell, N.J., company did not investigate a portable aspirator that failed to operate due to a disconnection of a battery terminal wire. The problem occurred three days after the customer received the product, which had been repaired because of a similar problem, the letter says. Impact also had 28 nonconforming material record sheets for a leak test failure for one ventilator model.
The GMP Letter