483
Patheon Biologics (NJ) LLCPatheon Biologics (NJ) LLC – FDA 483, Jun 20, 2018
Record Details
An FDA inspection of Patheon Biologics (NJ) LLC in Princeton, New Jersey, revealed two significant observations related to their laboratory and quality systems. The firm was cited for inadequate control of electronic laboratory data to prevent alteration or deletion, and for lacking written responsibilities and procedures for its quality control unit, including an enterprise-wide quality policy.
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ID · 518e46d1-2060-4e2b-bfd8-2cc2cbffdc18
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