NuCare Pharmaceuticals Listing Violations

FDA says it manually reviewed over 200 of NuCare Pharmaceuticals’ listing files from 8/2017 to the present and identified “many instances where the listing information failed to comply with the applicable requirements.” A 9/26 Warning Letter says the firm has failed to address many of the listing deficiencies detailed in multiple 2017 and 2018 deficiency letters addressed to the company.

The agency says that while NuCare has made some corrections, many other listing issues remain unresolved. The letter includes a chart with examples of existing violations included in deficiency letters and examples of errors found in more recent drug listing submissions.

NuCare was told to respond with a list of specific steps it has taken and will take to promptly identify and correct each violation to bring all of its products into compliance, with a schedule for completion of the steps.