FDA 483 - Ramco Laboratories, Inc - January 22, 2020

Ramco Laboratories, Inc. in Stafford, TX, an IVD manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate device master records, lack of process and stability validations for their IVD devices, and unapproved changes to specifications, methods, and processes. Additionally, the firm's corrective and preventive action procedures were found to be insufficient, leading to uninvestigated recurring product nonconformances.