FDA 483 - Tegra Medical Costa Rica Sa - June 29, 2023

During an inspection conducted from June 26-29, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Tegra Medical Costa Rica Sa, a contract manufacturer. The inspection revealed an inadequacy in the firm's quality system, specifically regarding its procedures for corrective and preventive action (CAPA). The primary observation noted that Tegra Medical's CAPA procedure (SCP-0003 Rev 28) was not adequately established. It failed to properly identify or reference another crucial procedure (CR-WI-0233) that outlines the severity classification matrix used within the CAPA process. This lack of clear cross-referencing between essential quality system documents indicates a deficiency in the firm's documented procedures for addressing non-conformances and preventing their recurrence. The Form FDA-483 serves as notice of observed objectionable conditions, reminding the firm of its responsibility under the Federal Food, Drug, and Cosmetic Act to conduct internal self-audits and correct all quality system violations. While this document does not represent a final determination of compliance, Tegra Medical has acknowledged the observation and promised to correct the identified procedural deficiencies.