FDA 483 - Amgen Manufacturing Ltd - September 08, 2021

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.