Contract Testing Lab Draws Warning Letter Over GMP Lapses

Missouri Analytical Laboratories, a contract drug testing facility, has drawn a Warning Letter from the FDA for failing to comply with good manufacturing practices.

The agency’s warning followed an unsatisfactory response by the company to inspection observations, including a failure to fully investigate unexplained out-of-specification (OOS) results, and investigations that were closed “without adequate scientific justification.”

For example, the company “relied on resampling and retesting to invalidate” OOS results for an active pharmaceutical ingredient results without identifying a root cause, the FDA said.