483
Nissui CorporationNissui Corporation – FDA 483, Nov 11, 2022
Record Details
An FDA inspection of Nippon Suisan Kaisha, Ltd. Kashima, a manufacturer of active pharmaceutical ingredients, revealed significant deficiencies. Observations included inadequate laboratory controls, specifically regarding data integrity and system access, and insufficient equipment cleaning procedures. Additionally, master production and control records were found to be incomplete, lacking justifications for yield variations and proper deviation instructions.
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ID · 2f7b408e-d24a-470b-9cbd-1fd1c992acb1
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