483
Amgen Manufacturing LtdFDA 483 - Amgen Manufacturing Ltd - September 08, 2021
Record Details
Amgen Manufacturing Limited in Juncos, P.R., received a Form 483 citing significant deficiencies in quality control and documentation practices. Observations included inadequate testing of components from unqualified suppliers, failure to document production events in real-time, and a lack of thorough investigations into unexpected results and inventory discrepancies. These issues indicate a need for improved adherence to GMP regulations regarding material control, record-keeping, and quality system investigations.
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ID · 4e22eb82-c1e0-40d2-9885-de04bda03b61