483
Tepha IncorporatedTepha Incorporated – FDA 483, May 13, 2022
Record Details
An FDA inspection of Tepha Incorporated in Lexington, MA, from May 11-13, 2022, identified one significant observation. The firm's procedures for corrective and preventive action were found to be inadequately established. Specifically, the effectiveness check for CAPA #1121 was deemed insufficient.
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ID · 0ce8abb5-6b08-47e1-91ff-739a9d537656
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