483
DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - HennriettaDJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta – FDA 483, Oct 12, 2023
Record Details
This 483 report for DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Henrietta, a medical device manufacturer in Rochester, NY, details significant deficiencies in their quality system. The inspection revealed inadequate procedures for controlling nonconforming products and corrective and preventive actions. Furthermore, the firm failed to document critical design control activities, including design validation, verification, inputs, reviews, and plans for their anoscope products.
- Inspection date
- October 12, 2023
- Product type
- device
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ID · 034c418f-7b92-49ef-b398-6ffe5b204ef8
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