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483
•Amgen Manufacturing Ltd•September 27, 2019

FDA 483 - Amgen Manufacturing Ltd - September 27, 2019

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Record Details

An FDA Pre-Approval Inspection of Amgen Manufacturing Limited in Juncos, PR, identified two significant observations. The firm was cited for failing to maintain complete batch production and control records and for not establishing adequate control procedures to validate manufacturing processes, specifically regarding process performance qualification documentation.

Company
Amgen Manufacturing Ltd
Inspection Date
September 27, 2019
Product Type
Biologics
Office
Division of Human and Animal Food Operations - East IV
Person
  • Noreen Muniz (Investigator)
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ID · 2514ea02-8069-40d4-9b32-3a9649c22c06

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