FDA WARNING_LETTER - First Pharma Associates LLC dba Riverpoint Pharmacy - December 16, 2016

On September 12, 2017, the FDA issued a Warning Letter to First Pharma Associates, LLC, dba Riverpoint Pharmacy, following an inspection from December 6-16, 2016. The inspection revealed that the pharmacy produced drug products that failed to meet the conditions for exemption under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), and exhibited serious deficiencies in non-sterile drug product production.

Specifically, the firm compounded drug products using peruvian balsam and zinc picolinate, which are not eligible for 503A exemptions as they lack USP/NF monographs, are not components of FDA-approved drugs, and are not on the 503A bulks list. These "ineligible drug products" are therefore subject to FDA approval, adequate labeling, and CGMP requirements.

Violations included adulterated drug products due to insanitary conditions, such as difficult-to-clean surfaces, an ISO 5 laminar flow hood in an unclassified, non-HEPA-filtered room with a sink, and failure to demonstrate adequate protection of the ISO 5 area. The ineligible drug products were also deemed misbranded under Section 502(f)(1) of the FDCA because they lacked adequate directions for use for laypersons.

The FDA found the firm's January 9, 2017, response to the Form FDA 48