FDA WARNING_LETTER - ECI Pharmaceuticals, LLC - February 15, 2022

The FDA issued a Warning Letter to John Copanos on February 3, 2022, regarding drug listing deficiencies for "esterified estrogens and methyltestosterone" (NDC 51293-639 and 51293-640). The firm incorrectly listed "conjugated estrogens" as the active ingredient in the electronic listing file, while the product labeling correctly identified "esterified estrogens." These are distinct active ingredients.

This violates Section 510(j) of the FD&C Act and 21 CFR 207, which require accurate listing of active pharmaceutical ingredients. The FDA previously notified the firm of these deficiencies on October 26, 2021, and removed the products from the Online NDC Directory on December 10, 2021, due to continued non-compliance.

Failure to properly list drugs renders them misbranded under Section 502(o) and constitutes prohibited acts under Sections 301(p) and 301(a) of the FD&C Act. Accurate registration and listing are crucial for patient safety, inspections, supply chain security, and post-market surveillance.

The firm must respond within 15 working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure and injunction.