483
Sterigenics Radiation Technologies IN, IncFDA 483 - Sterigenics Radiation Technologies IN, Inc - September 19, 2024
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Record Details
An FDA inspection of Sterigenics Radiation Technologies IN, Inc. in Columbia City, IN, a contract sterilizer, identified two significant observations. The firm was cited for inadequate validation of a critical test method, lacking statistical rationale for established limits, and for deficiencies in their corrective and preventive action procedures, including an outdated pFMEA.
- Inspection Date
- September 19, 2024
- Product Type
- Device
- Office
- Detroit District Office
- Person
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ID · 54511597-a5ac-46c5-a762-91928102946a