483
Stephens Instruments, IncFDA 483 - Stephens Instruments, Inc - October 26, 2023
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Record Details
An FDA inspection of Stephens Instruments, Inc., a medical device manufacturer in Lexington, KY, identified one observation. The firm's procedures for ensuring purchased products and services conform to specified requirements were found to be inadequate. This deficiency led to the approval of a contract medical device manufacturer that did not have an active registration on record.
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