483
Tristel Solutions LimitedFDA 483 - Tristel Solutions Limited - February 13, 2025
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Record Details
An FDA inspection of Tristel Solutions Limited, a medical device manufacturer in Snailwell, United Kingdom, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, insufficient control over non-conforming products, and incomplete documentation of design validation results. These issues indicate a need for improved quality management practices at the facility.
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