FDA 483 - Plas-Tech Engineering Inc. - January 24, 2011

Plas-Tech Engineering Inc., a medical device contract manufacturer in Lake Geneva, WI, received an FDA Form 483 citing multiple deficiencies in its quality system. The inspection revealed significant gaps in established procedures for internal audits, purchasing controls, corrective and preventive actions, complaint handling, Medical Device Reporting (MDR), and control of nonconforming product. These observations indicate a need for comprehensive improvements to the firm's quality management system.