483
Ash Stevens LLCFDA 483 - Ash Stevens LLC - July 09, 2009
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An FDA inspection of Ash Stevens Inc. in Riverview, MI, revealed two significant observations related to their API manufacturing operations. The firm failed to implement adequate procedures for handling approved solvents during dispensing, posing a risk of cross-contamination. Additionally, written procedures for the preventative maintenance of production equipment were not followed, resulting in missing and incomplete documentation.
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ID · 1605c765-13c5-46ed-bafa-96a3bebfa97a