FDA EIR - Torbot Group, Inc., Jobskin Div. - September 14, 2017

An FDA inspection of Torbot Group Inc. Jobskin Division, a manufacturer of Class I and Class II non-sterile medical devices, primarily vascular compression garments, was conducted from September 11-14, 2017. This QSIT Level I inspection was carried out in accordance with CPGM 7382.845. The inspection team discussed three observations with company management, though no formal FDA-483 was issued. The main issues identified were: the rework procedure lacked a formal statement ensuring evaluation of reworked devices prior to release (despite the evaluations being performed); one employee's training record was not documented contemporaneously with the training completion; and certain quality documents, specifically action and error forms, were not identified as required by the firm's document control procedure. Company management was cooperative, acknowledged these observations, and agreed to implement the necessary corrections. Notably, the firm had successfully addressed and corrected two observations from a prior inspection in 2014 concerning design change procedures and quality audits.