483
Evologics, LLCEvologics, LLC – FDA 483, Aug 27, 2019
Record Details
This FDA Form 483 was issued to EvoLogics, LLC in San Antonio, TX, following an inspection of their HCT/P establishment. The inspection revealed significant deficiencies primarily related to adverse event reporting, HCT/P tracking and disposition, and record-keeping practices. These issues indicate a lack of adequate controls over critical quality system elements.
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ID · d2df915d-f002-4b95-ae8c-5cd3a58a3150
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