FDA EIR - Calvert Laboratories, Inc. - July 25, 2018

An FDA inspection of Calvert Laboratories, Inc., a contract research organization, was conducted from July 23-25, 2018. This Good Laboratory Practice (GLP) data audit, performed under the Prescription Drug User Fee Act (PDUFA) and Compliance Program 7348.808, evaluated the firm's adherence to regulatory standards for non-clinical laboratory studies, primarily covering human drug studies under 21 CFR Part 58.The inspection concluded without the issuance of an FDA Form 483, indicating no significant objectionable conditions requiring formal observation. However, several discussion items were raised with management. These included observations of feed bags stored too close to facility walls, which could impede pest control efforts; the presence of minimal formalin in certain archived histology wet tissues from an approximately ten-year-old study, though the firm provided documentation to address this; and the discovery of animal feces on the floor in a clean cage room. Additionally, an inconsistency was noted where a test article formulation was not stirred during dosing activities, despite stirring being part of the validation process.Calvert Laboratories

management acknowledged these discussion points and committed to implementing immediate corrective actions, particularly for the sanitation and feed storage issues. The firm had previously addressed a water hardness issue from a 2016 inspection by updating its standard operating procedures.