FDA 483 - CHRI Laboratories, Inc. - May 03, 2023

ChRi Laboratories, Inc. in St. Paul, MN, a contract laboratory, was cited for significant deficiencies during an FDA inspection. Observations included inadequate qualified personnel for drug product processing, unestablished accuracy and reproducibility of test methods, and a lack of scientifically sound rationale for microbiology laboratory cleaning procedures. One observation regarding personnel was a repeat from a previous inspection, indicating persistent issues.