FDA WARNING_LETTER - Hybrid Pharma, LLC - September 03, 2021

The FDA issued a Warning Letter to Hybrid Pharma, LLC, an outsourcing facility, following an inspection from July 27 to September 3, 2021. The inspection revealed that the facility's drug products failed to meet the conditions of section 503B of the FDCA and exhibited serious deficiencies in sterile drug production, posing patient risks. Specifically, Hybrid Pharma failed to submit complete drug product reports to the FDA in December 2020 and June 2021, violating section 503B(b)(2) of the FDCA. This failure renders their compounded drugs ineligible for 503B exemptions, making them subject to new drug approval requirements and adequate labeling directions.

The facility also committed several CGMP violations, causing drug products to be adulterated under section 501(a)(2)(B) of the FDCA. These include failing to thoroughly investigate discrepancies (21 CFR 211.192), establish test method accuracy (21 CFR 211.165(e)), and maintain an adequate environmental monitoring system in aseptic areas (21 CFR 211.42(c)(10)(iv)). Furthermore, the firm markets unapproved new drugs, violating sections 505(a) and 301(d), and produces misbranded drug products due to inadequate directions for use (section 502(f)(1)). The repeated failure to report drugs also constitutes a prohibited act under section 301(ccc)(3).

The FDA found the firm's initial corrective actions deficient due to a lack of supporting documentation for investigations, method validation, and updated monitoring procedures. The agency strongly recommends a comprehensive assessment of operations, including aseptic processing, with the assistance of a third-party consultant. Hybrid Pharma must respond within fifteen working days with specific steps taken to correct violations and prevent recurrence, including supporting documentation, to avoid potential legal action such as seizure and injunction.