483
Daiichi Sankyo Chemical Pharma Co., Ltd.FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - January 25, 2019
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Record Details
An FDA Form 483 was issued to Daiichi Sankyo Chemical Pharma Co., Ltd. in Odawara, Japan, an API manufacturer. The inspection revealed deficiencies related to the retention of documentation for primary reference standards, the suitability determination of secondary reference standards, stability testing practices for drug substance intermediates, and the thoroughness of investigations into unexplained discrepancies.
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