Infusion Options, Inc. – FDA Warning Letter, Jun 25, 2019

This FDA Warning Letter (WL # 612459) dated August 26, 2021, addresses Infusion Options, Inc. following inspections from May 6 to June 25, 2019, at their Brooklyn, NY facility and warehouse. The company was registered as an outsourcing facility under section 503B of the FDCA from January 24, 2014, until its withdrawal on July 5, 2019.

The FDA found that drug products produced by Infusion Options failed to meet 503B conditions, thus not qualifying for exemptions from drug approval, adequate directions for use, and Drug Supply Chain Security Act requirements. Specific violations include: 1. **Labeling Deficiencies:** Drug products lacked required statements like "This is a compounded drug," "not for resale," compounding date, lot/batch number, and adverse event reporting information (www.fda.gov/medwatch and 1-800-FDA-1088). 2. **Failure to Report:** The facility failed to submit required semi-annual reports to the FDA in June 2014, December 2016, December 2017, June 2018, December 2018, and June 2019, identifying compounded drug products.

Additionally, the FDA noted serious deficiencies in sterile drug product