483
SCI Pharmtech Inc.SCI Pharmtech Inc. – FDA 483, Jun 6, 2025
Record Details
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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