FDA EIR - Encompass Group LLC - January 08, 2020

An FDA inspection of Encompass Group LLC, a manufacturer of Class I and Class II medical devices, took place from January 6-8, 2020, in McDonough, GA. Conducted under Compliance Program 7382.845 for medical device manufacturers, this Level I QSIT inspection focused on management controls, corrective and preventive actions (CAPA), and production and process controls. The company is registered as a Specification Developer, Complaint File Establishment, Contract Manufacturer, and Repackager/Relabeler.

While no significant deficiencies in the Quality System Regulations were identified during this inspection, and no Form FDA 483 was issued, management discussions highlighted several areas for attention. These included the absence of documented evidence for internal audits scheduled for May-December 2018, the lack of a formal quality agreement with a critical Class II device supplier, incomplete preventive maintenance records for certain equipment in April and October 2019, and the presence of both current and expired calibration stickers on equipment. Management confirmed they would address these concerns.

Regarding a previous 2017 inspection that resulted in a Form FDA 483, Encompass Group LLC had implemented voluntary corrective actions for undocumented personnel training and inadequate document control, which were found to be effectively addressed. However, issues related to comprehensive quality audits and equipment preventive maintenance procedures, observed in the prior inspection, re-emerged as discussion points in the current review.