FDA 483 - PRO-TECH Design & Mfg., Inc. - April 14, 2025

PRO-TECH Design & Mfg., Inc. in Arlington, TX, was inspected by the FDA from April 10-14, 2025. The inspection revealed a significant issue regarding the lack of documentation for major equipment used in a validated process. Specifically, the firm failed to validate its burst strength testing process and the associated Burst Strength Tester, which has been in use since 2012 for testing packaging seals.