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483
•Patheon Biologics (NJ) LLC•June 20, 2018

FDA 483 - Patheon Biologics (NJ) LLC - June 20, 2018

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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.

Company
Patheon Biologics (NJ) LLC
Inspection Date
June 20, 2018
Product Type
Biologics
Office
New Jersey District Office
Person
  • Frederick Razzaghi (Advisor)
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ID · 518e46d1-2060-4e2b-bfd8-2cc2cbffdc18

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