483
Patheon Puerto Rico, Inc.Patheon Puerto Rico, Inc. – FDA 483, Jul 31, 2026
Record Details
An FDA inspection of Patheon Puerto Rico, Inc. in Manati, PR, revealed significant deficiencies in quality control and adherence to written procedures. The firm failed to adequately test incoming high-risk drug components and lacked scientific justification for its sampling methods. Additionally, production operators did not properly document sample collection times as required by established procedures, indicating a breakdown in process control.
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ID · 3187c49f-7b57-44fd-a65d-9e6ca4763f9a
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