483
Apotex Pharmachem Inc.Apotex Pharmachem Inc. – FDA 483, Dec 16, 2022
Record Details
An FDA inspection of Apotex Pharmachem Inc. in Brantford, Canada, an API manufacturer, identified two significant observations. The firm's validation of a stability-indicating method for an active pharmaceutical ingredient was deemed inadequate, with issues in forced degradation studies. Additionally, the inspection revealed a failure to sign off and lock completed projects in their EMPOWER 3 computerized system, which is contrary to their established standard operating procedures.
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ID · 9bbf8346-eb7e-43f3-ba51-df5354bce5b2
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