Exela Pharma Sciences LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your facility’s procedures for reporting adverse events are inadequate. For example, at the time of the inspection, your documented procedures only covered “NDA/ANDA products” and makes no reference to the required adverse event submission process utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG).

Passage 2

You do not have any FDA-approved applications on file for drug products that you compound.

Passage 3

You compound drug products that are intended for conditions not amenable to self- diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.