FDA 483 - Richie Pharmacal Company Inc - December 10, 2024

During an inspection, the FDA observed that your firm"s systems and processes for complying with the Drug Supply Chain Security Act (DSCSA) verification requirements (Section 582(c)) are inadequate. A key issue is the firm"s unsigned procedure, SOP 7.19, "Suspect and Illegitimate Product," which fails to outline proper steps for terminating illegitimate product notifications, identifying suspect products, conducting investigations with trading partners, including package-level verification, and notifying FDA when suspect product is not illegitimate. Additionally, it contains an invalid link to FDA Form 3911. Another procedure, SOP 3.11, "Receiving Instructions," incorrectly states that product disposition is authorized by the board of pharmacy and FDA, whereas the DSCSA mandates firms to manage illegitimate product disposition. The firm also lacks adequate training programs and corresponding records for employees responsible for identifying and receiving suspect and illegitimate products. Furthermore, several critical Standard Operating Procedures, including "Receiving instructions," "Warehousing and shipping," "Authenticating Vendors," and "Suspect and illegitimate product," were found to lack essential review and approval signatures. To address these observations, the firm must implement robust systems, revise its procedures to align with DSCSA requirements, establish comprehensive training programs with proper documentation, and ensure all SOPs are formally reviewed and approved.