483
Welmed Inc.Welmed Inc. – FDA 483, Feb 19, 2026
Record Details
An FDA inspection of Welmed Inc., a manufacturer and specifications developer of Class II syringes in Chicago, revealed two significant observations. The firm failed to adequately document justifications for not investigating complaints of foreign material in its Class II syringes. Additionally, Welmed Inc. did not maintain proper records of risk management activities related to product realization, including design risk assessments and new risk analyses for supplier changes.
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ID · 4c8ed25a-247b-45d4-986d-35c848f0387d
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