483
Sachem Europe BVFDA 483 - Sachem Europe BV - February 06, 2020
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Sachem Europe BV, an API Intermediate Manufacturer in Zaltbommel, Gelderland, Netherlands, was inspected by the FDA from February 3-6, 2020. The inspection resulted in one observation concerning the firm's failure to fully follow written laboratory control procedures. Specifically, deviations were noted in HPLC analysis run times without proper documentation.
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ID · f45db336-09ab-4eda-bf81-a797b7778a7b