Inefficient OOS Analyses lead to FDA Warning Letter

Recently the U.S. FDA (Food and Drug Administration) gave a warning letter to Professional Disposables International, Inc, located in Orangeburg, New York, dated January 7, 2022, due to insufficient investigations into out-of-specification (OOS) test results.

The FDA also inspected the drug manufacturing facility Professional Disposables International, Inc, located in Orangeburg, New York, in May and June 2021. During that check, the FDA investigators observed typical GMP violations.

In the warning letter, different instances are mentioned. As per the FDA, in all of these instances, the QU (quality unit) finalized that without sufficient scientific justification, the analytical error was the most probable root cause for the initial OOS results. The company also failed to begin a "production review or CAPA following the investigations, along with a comprehensive evaluation of the product development, previous failing results obtained, manufacturing validation, and analytical test method."