FDA 483 - R.D. Laboratories Inc. - January 26, 2024

R.D. Laboratories Inc., a contract testing laboratory in Washington, MO, was cited for significant deficiencies during an FDA inspection. The inspection revealed failures in verifying the suitability of analytical testing methods and critical lapses in computer system controls, including a lack of audit trails and inadequate user access management for laboratory instruments. These issues indicate potential risks to data integrity and product quality.