FDA WARNING_LETTER - Heritage Pharmaceuticals, Inc. DBA AVET Pharmaceutical LABS - May 27, 2015

On May 27, 2015, the FDA issued a Warning Letter to Heritage Pharmaceuticals, Inc. following an inspection from May 12-27, 2015, which revealed serious violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements under Section 505(k) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.80 and 314.98.

The violations include:

1. **Failure to report each adverse drug experience at quarterly/annual intervals:** Between 2010 and 2014, Heritage Pharmaceuticals failed to submit approximately (b)(4) individual case safety reports (ICSRs) with their respective quarterly and/or annual Periodic Adverse Drug Experience Reports (PADERs), affecting at least (b)(4) abbreviated new drug applications (ANDAs). For example, for (b)(4), approximately ten ICSRs were omitted from annual PADERs between 06/2010 and 06/2014. The firm's reliance on a contractor for PADERs was deemed insufficient, as the application holder is ultimately responsible. The firm's response to submit amended PADERs was inadequate, lacking details on preventative measures like SOPs, database access, and staff training.

2. **Failure to develop adequate written procedures for PADE surveillance, receipt,