FDA 483 - Sheffield Precision Medical Limited - October 23, 2025
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Sheffield Precision Medical Limited, a medical device manufacturer in Sheffield, United Kingdom, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for corrective and preventive actions, equipment maintenance, and in-process product control. Furthermore, critical manufacturing processes were not fully validated, and device history records were found to be incomplete and inconsistent with regulatory requirements.
ID · 27fb2825-9bb3-4272-9c09-ae38329715a1