Sonoco TEQ Llc – FDA 483, Jun 10, 2022

Sonoco TEQ Llc in Fremont, IN, received a Form 483 with three observations concerning its manufacturing processes for Class II medical devices. The firm was cited for failing to establish procedures for monitoring and controlling validated process parameters, operating outside validated ranges, and using an inadequately validated manufacturing process without proper rationale for sterile barrier confirmation. Additionally, inspection equipment used for sterile barrier packaging was found to be uncalibrated for its intended use range.