Devicemakers Lack Understanding of Correction, Removal Rules

Devicemakers often do not have a good understanding of the FDA’s requirements for corrections and removal reports, which can lead to enforcement action.

Areas manufacturers find particularly confusing are the records they must keep and what they must report to the FDA, Dan O’Leary, president of Ombu Enterprises, said during an FDAnews virtual conference.

Every devicemaker or importer must keep records of corrections and removals that are not reported to the FDA, he said.
The GMP Letter