By unidentified

Published in: ECA Academy

Published on: January 26, 2022

Introduction: Recently the U.S. Food and Drug Administration (FDA) issued a warning letter dated January 7, 2022, due to inadequate investigations into out-of-specification (OOS) test results.

In May and June 2021, the FDA inspected the drug manufacturing facility Professional Disposables International, Inc, located in Orangeburg, New York. During that inspection, the FDA investigators observed specific GMP violations.

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