The FDA has issued a Warning Letter to Acorda Therapeutics Inc. following an inspection conducted between August 15, 2011 and September 9, 201.

The first postmarketing adverse drug experience (ADE) reporting compliance inspection of Acorda Therapeutics was conducted in 2006. Observations from the 2006 inspection included late submission of 15-day Alert reports, failure to develop written procedures, and failure to submit follow-up reports. A second postmarketing ADE reporting compliance inspection of Acorda Therapeutics was conducted in 2009. Observations from the 2009 inspection included late submission of Field Alert Reports and the repeat findings of late submission of 15-day Alert reports and failure to develop written procedures. Additionally, during the 2009 inspection, the FDA Investigator noted that your firm did not complete corrective actions until 2007, even though your response to FDA, dated January 19, 2006, stated that all corrections had been made.
 
Specific violations observed during the inpsection conducted in August 2011, include but are not limited to the following:
  1. Failure to submit all adverse drug experiences (ADEs) that are both serious and unexpected to FDA within 15 calendar days of initial receipt of the information as required by 21 CFR 314.80(c)(1)(i).
  2. Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences (ADEs) from all sources as required by 21 CFR 314.80(b). 
  3. Failure to maintain records of all adverse drug experiences known to you, including raw data and any correspondence relating to adverse drug experiences, for a period of 10 years as required by 21 CFR 314.80(i).  
  4. Failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals as required by 21 CFR 314.80(c)(2)(i).