Southern Tier Home Infusion, Inc. dba Pharmacy Innovations
Southern Tier Home Infusion, Inc. dba Pharmacy Innovations, a compounding pharmacy in Erie, PA, received an FDA Warning Letter following a November 2022 inspection that found sterile drug products produced under insanitary conditions, including rust, microbial contamination, inadequate HEPA filtration, and poor aseptic operator practices. The firm also compounded drug products — including Lidocaine/Tetracaine/Phenylephrine 20/4/2% Gel and Dutasteride 0.1% Injectable — without valid patient-specific prescriptions, disqualifying them from section 503A exemptions and rendering them unapproved new drugs and misbranded products. FDA acknowledged the firm's voluntary recall of all sterile compounded products and cessation of sterile compounding in the affected area, but found several corrective action responses insufficient. The letter warns that failure to adequately address violations may result in seizure or injunction.
Flagged claims (4)
You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.
your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced, including Lidocaine/Tetracaine/Phenylephrine 20/4/2% Gel and Dutasteride 0.1% (1.5mL Vial) Injectable
drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health
their labeling fails to bear adequate directions for their intended uses
Required actions (4)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs intended or expected to be sterile inside the non-hazardous cleanroom suite.
you should notify this office fifteen (15) working days prior to resuming production of any drugs intended or expected to be sterile in the future.
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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