483
Resilience US, IncFDA 483 - Resilience US, Inc
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Record Details
An FDA inspection of Resilience US, Inc, a Cell and Gene Therapy Contract Manufacturer in Durham, NC, revealed five observations. The firm was cited for inadequate procedures regarding deviation classification and trending, undefined retesting procedures for Out of Specifications, a deficient disinfectant efficacy study, and deficiencies in incoming component testing.
- Company
- Resilience US, Inc
- Product Type
- Biologics
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ID · d87ed3f0-2ffe-45f3-8d91-d3653ebba1b7