483
Isomedix Operations Inc.Isomedix Operations Inc. – FDA 483, Nov 7, 2019
Record Details
An FDA inspection of Isomedix Operations Inc., a contract sterilizer in Chester, NY, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for the control of in-process medical device products, leading to potential mix-ups and incorrect processing. Additionally, the inspection found that the company did not maintain required distribution records for a medical device product.
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ID · 6444098d-f926-430d-90df-9f5ba6c37dc2
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