www.fdanews.com/articles/184100-company-failed-to-check-out-patients-drug-complaint-fda-says
Company Failed to Check Out Patient’s Drug Complaint, FDA Says
October 24, 2017
A Texas drugmaker was flagged by the FDA for failing to follow up on a patient’s complaint.
The company, Neos Therapeutics, of Grand Prairie, did not investigate a complaint of dizziness and difficulty sleeping after taking Adzenys (amphetamine), an extended-release tablet for treating attention deficit hyperactivity disorder in patients 6 years and above.
The company also did not document why it didn’t look into the complaint, the FDA said in a Form 483 report.