483
Sharps Compliance, Inc.FDA 483 - Sharps Compliance, Inc. - January 19, 2024
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An FDA inspection of Sharps Compliance, Inc. in Houston, TX, a specification developer, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures and implementation regarding design changes, complaint handling, and supplier controls. These issues are particularly concerning as several observations were repeats from a previous inspection.
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