Encompass Group LLC – FDA 483, Jul 2, 2026
Encompass Group LLC, a medical device manufacturer in McDonough, GA, was inspected and received a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality management system, including inadequate corrective and preventive actions, a lack of timely internal audits, and insufficient maintenance of personnel training records. Several issues, particularly regarding internal audits and training, were repeats from previous inspections, indicating persistent non-compliance.
- Office
- Atlanta District Office
- Person
ID · 7bd71999-c502-4c04-934c-48664ba0d60d
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