FDA 483 - Diagnostic Services of Kansas State, Inc. - June 20, 2025

The FDA inspected Kansas State Veterinary Diagnostic Laboratory, a contract laboratory in Manhattan, KS, and issued a Form 483 with four observations. The inspection revealed significant deficiencies including failure to calibrate equipment used for drug product potency testing, incomplete batch production and control records, inadequate laboratory records for sample descriptions, and non-adherence to written production and process control procedures. These issues indicate a lack of control over critical testing processes and record-keeping.