L.A.D. Global Enterprises received a Form 483 after an inspection in October revealed the Olathe, Kansas firm had multiple noncompliances, including a failure to establish written procedures for MDRs.
The FDA noted one of the firm’s CAPA procedures was missing provisions for analyzing quality reports to identify nonconforming products, their causes, and other quality concerns.
Provisions were also missing for investigating the causes of quality system nonconformities and verifying and validating CAPAs to be sure they are effective and free of adverse effects. The CAPA procedure also failed to ensure that the information gathered about nonconforming products and quality issues reached the person directly responsible for dealing with them.