483
AGC Biologics, Inc.AGC Biologics, Inc. – FDA 483
Record Details
ICMC Biologics, Inc, dba AGC Biologics in Bothell, WA, received a Form 483 with four observations following an FDA inspection from October 4-15, 2018. The inspection revealed significant deficiencies in contamination control, facility maintenance, corrective action procedures, and electronic record integrity. These issues indicate a lack of robust quality systems and controls in critical manufacturing and data management areas.
- Company
- AGC Biologics, Inc.
- Product type
- biologics
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ID · f364fb7c-8e0e-47cb-905e-2ec30672b2c1
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