483
Thompson Ocular Prosthetics, IncThompson Ocular Prosthetics, Inc – FDA 483, Jul 2, 2025
Record Details
Thompson Ocular Prosthetics, Inc. in San Antonio, TX, was inspected regarding its manufacturing of Class II medical devices. The inspection revealed significant and systemic failures in their quality management system, including repeat observations from a previous 2021 inspection. Key issues involved inadequate design controls, corrective and preventive actions, complaint handling, quality audits, management review procedures, and personnel training.
- Office
- Dallas District Office
- Person
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ID · 12f05d00-d397-4647-9e6e-c28fedf29016
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