Iowa drug manufacturer Continental Manufacturing Chemist drew a Form 483 from the FDA for quality failures at its Madrid facility.

An FDA inspection found that the facility had just one person in its quality unit for analytical testing, and the agency investigator noted that no OOS events were reported in the past year.

Analytical tests that failed to meet specifications were sent to the company’s Huxley facility to determine if an OOS report was required. Analytical samples for raw materials, in-process and finished products were sent to the Huxley facility for testing, but there was no documentation or archiving of the requests for testing.