483
Grand River Aseptic Manufacturing, Inc.FDA 483 - Grand River Aseptic Manufacturing, Inc. - September 19, 2024
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Record Details
Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI, was inspected by the FDA from September 16-19, 2024. The inspection revealed issues related to manufacturing process validation and documentation practices. Specifically, a syringe filling line validation study did not simulate all necessary steps, and unplanned activities were not timely documented in batch records.
- Inspection Date
- September 19, 2024
- Product Type
- Biologics
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