483
Amgen Manufacturing LtdFDA 483 - Amgen Manufacturing Ltd - September 27, 2019
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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.
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ID · 2514ea02-8069-40d4-9b32-3a9649c22c06