Colorado Devicemaker Cited for Recordkeeping

July 9, 2019

The FDA hit Englewood, Colorado devicemaker Vitrolife with a Form 483 for failure to provide access to quality records.

During its Feb. 6-13 inspection, the agency was not able to view all the electronic records it requested due to a problem with the firm’s automated systems.

The investigator said that the firm failed to provide records of management controls, internal audits, CAPAs, complaint handling, nonconforming products, process validations, change controls and calibration and maintenance.

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