Carolina Infusion

their labeling fails to bear adequate directions for their intended uses. Accordingly, these ineligible drug products are misbranded under section 502(f)(1) of the FDCA.

your firm did not receive valid prescriptions for individually identified patients for a portion of the drug products you produced, including Tri-Mix 30/2/20 Injectable, Lidocaine/Tetracaine/Phenylephrine 21%/7%/2% Ointment, and Lidocaine/Tetracaine 23%/7% Plasticized.

You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.

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

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. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

FDA acknowledges that on August 26, 2022, your firm initiated a voluntary recall of all products intended to be sterile that were within expiry due to a lack of sterility assurance.

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

FDA strongly recommends, especially if you decide to resume production of sterile intrathecal drug products, your management undertake a comprehensive assessment of operations, including but not limited to establishing product endotoxin limit, facility design, procedures, personnel, processes, maintenance, materials, and systems. A third-party consultant with relevant sterile drug manufacturing expertise including intrathecal and endotoxin testing should assist you in conducting this comprehensive evaluation.