Hybrid Pharma, LLC
FDA issued a warning letter to Hybrid Pharma, LLC, a 503B outsourcing facility in Deerfield Beach, FL, following a July–September 2021 inspection that revealed CGMP violations, failure to submit complete drug product reports, and production of adulterated, misbranded, and unapproved new drug products. The facility failed to thoroughly investigate batch discrepancies, establish validated test methods, and maintain adequate environmental monitoring for aseptic processing. Drug products including Phosphatidyl choline 5% and deoxycholate 4.2% injectable were compounded without meeting 503B conditions, rendering them ineligible for exemptions from FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA
You do not have any FDA-approved applications on file for drug products that you compound.
your facility failed to submit a complete report to FDA in December 2020 and June 2021, identifying all the drug products that you compounded during the previous 6-month period, including Phosphatidyl choline 5% and deoxycholate 4.2% injectable
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
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