Documentation errors can lead to big trouble

Documentation errors can lead to big trouble. In a recent FDA Warning Letter, a company was notified that their filing and labeling did not match!

Specifically, the active ingredients described under the Drug Facts section of the labeling and Principal Display Panel image are acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine, while the active ingredients included in the electronic listing file in (SPL) are acetaminophen, dextromethorphan hbr, phenylephrine, and guaifenesin. The active ingredient doxylamine is missing from the electronic listing file in (SPL) and instead guaifenesin is included.1
Labeling and documentation errors can result in regulatory problems and, worse, adverse events in patients. When using an Electronic Document Management System (eDMS) such errors can be avoided by:
Make sure your eDMS is up to date and up to snuff.
1Procter & Gamble Manufactura S. de R.L. de C.V. – 650837 – 03/14/2023
Center for Drug Evaluation and Research