483
Terumo BCT Sterilization Services, Inc.Terumo BCT Sterilization Services, Inc. – FDA 483, Oct 14, 2015
Record Details
Terumo BCT Sterilization Services, Inc. in Lakewood, CO, a contract sterilizer, received a Form FDA 483 with two observations. The inspection revealed that the firm had not adequately validated software used in production and lacked documented evaluations for a software engineering services supplier. These findings indicate deficiencies in the firm's quality system regarding software and supplier management.
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ID · a5b348b9-1bac-42ef-a05f-77bbd4572cd4
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