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483
•NANOFIBER SOLUTIONS, INC•October 29, 2021

NANOFIBER SOLUTIONS, INC – FDA 483, Oct 29, 2021

Record Details

NANOFIBER SOLUTIONS, INC in Dublin, OH, underwent an FDA inspection from October 25-29, 2021. The inspection resulted in one observation concerning inadequate process validation. Specifically, the firm failed to routinely perform Operational Qualification for critical foil pouch and sealing processes used for sterile medical devices.

Company
NANOFIBER SOLUTIONS, INC
Inspection date
October 29, 2021
Product type
device
Office
Cincinnati District Office
Person
  • Javonica F. Penn (investigator)
View Company Profile

ID · 8efcdf8f-7776-4b39-9854-b1686d04ca29

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