IVD Manufacturer Ramco Labs Written Up for Validation Failures

Ramco Laboratories failed to validate all its in vitro diagnostics (IVDs) and has a history of lax recordkeeping, FDA investigators found in an inspection of the firm’s Stafford, Tex., facility.

The company manufactures, assembles and markets diagnostic test kits, and supplies assays developed by academic, research and commercial institutions.

The FDA investigators found that the facility’s device master records lacked acceptance criteria, component specifications, production and process procedures, and other details.