483
SCI Pharmtech Inc.FDA 483 - SCI Pharmtech Inc. - June 06, 2025
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An FDA inspection of SCI Pharmtech Inc., an API manufacturer in Taoyuan City, Taiwan, revealed a significant issue with batch production records. The firm's records failed to include representative labels for APIs or commercially produced intermediates, indicating a deficiency in documentation practices. This observation highlights a concern regarding the completeness and accuracy of manufacturing records.
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ID · ad8a9849-6618-43b2-ada7-5addfaf165da