483
Francisco Lopez Godoy, MDFDA 483 - Francisco Lopez Godoy, MD - October 27, 2025
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Record Details
Panamericana Family Medicine Clinic in Houston, TX, was inspected regarding a non-significant risk device study. The inspection revealed that the clinical investigation did not meet abbreviated requirements for investigational device exemptions. Specifically, the firm failed to maintain adequate informed consent documents and ensure proper documentation of the informed consent process for study subjects.
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- Dallas District Office
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ID · e77081b8-455f-4f34-b8b0-6877fb9a2083