483
Patheon Puerto Rico, Inc.FDA 483 - Patheon Puerto Rico, Inc. - July 12, 2022
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Record Details
An FDA inspection of Patheon Puerto Rico, Inc. in Manati, PR, revealed significant deficiencies in their quality system and facility maintenance. The firm failed to follow established production and process control procedures and had deficient standard operating procedures. Additionally, the facility exhibited poor maintenance with water leakage and potential mold in the raw materials warehouse.
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ID · 264f9f13-3905-4bbe-b8df-0d23061cca38