Teleflex Form 483 Includes Five Repeat Observations

Teleflex was handed a Form 483 with five repeat observations and one fresh observation related to recall reporting after a May inspection.

The company recalled its Hudson RCI humidifier adaptor because the package seals might be creased, which could affect the sterility of the contents. However, this recall was not reported in writing to the FDA, according to the recently released form.

Meanwhile, procedures to monitor post sterility package integrity did not identify valid techniques for establishing, controlling and verifying process capability and product characteristics. And the statistical tool for CAPA trending failed to ensure that sampling methods are adequate. According to the form, this is a repeat observation cited during a previous inspection in 2013. Corrections have not been implemented, the FDA notes.

Teleflex’s CAPA procedures drew scrutiny as they did not require the company to verify or validate the corrective action. They did not identify the actions needed to correct and prevent the recurrence of nonconforming product. This is a repeat observation.

The company also took heat for its process validation procedures because it failed to review and evaluate the changes made to the form/fill/seal packaging process under a CAPA. “No revalidation was conducted prior to the continuation of manufacturing,” the letter says. This is a repeat observation.

Other repeat observations related to maintenance schedules, periodic inspections to verify maintenance schedules are observed.