The US FDA last month issued a warning letter to contract testing laboratory International Trading Pharmaceutical Laboratories (ITPL) over significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). During a two-week inspection in October 2019, the FDA found that ITPL’s Quality Unit had not acted on findings of an out-of-specification (OOS) investigation; chromatographic injections of samples were not included in the investigation or reviewed. Also, the client was not informed of OOS findings. Data from several samples tested with chromatographic injections were either omitted from the analyst’s notebook, or not included in the OOS investigation. Learn More