483
Ajinomoto Althea, Inc.Ajinomoto Althea, Inc. – FDA 483, Nov 22, 2019
Record Details
Ajinomoto Althea, Inc. in San Diego, CA, was inspected regarding its sterile drug manufacturing operations. The inspection revealed significant deficiencies in aseptic process validation, batch failure investigations, data integrity for computer systems, and laboratory controls for sample management, indicating a moderate level of severity regarding GMP compliance.
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ID · b884498d-ac8b-47e8-93de-b6bcee3250b3
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