Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine
Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine, operated by Dr. Leonard D. Guyer in Indianapolis, IN, received an FDA Warning Letter following a 2020 inspection that found the facility producing compounded sterile drug products under insanitary conditions and without meeting the conditions of section 503A of the FDCA. The facility used bulk drug substances including peptides such as BPC-157, thymosin alpha, thymosin beta, LL-37, Selank, and Semax that are ineligible for 503A exemptions, and produced drugs without valid patient-specific prescriptions. The violations encompass adulterated and misbranded drug products, unapproved new drug marketing, and serious CGMP deficiencies including unclassified sterile processing areas, lack of environmental monitoring, and improper aseptic technique. The firm was required to respond within 15 working days and must notify FDA 15 working days before resuming sterile production; failure to correct violations may result in seizure or injunction.
Flagged claims (7)
Your firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products you produced, such as your "(b)(4)" products, including Energy Boost.
You do not have any FDA-approved applications on file for the ineligible drug products that you compounded.
it appears that your facility may have produced biological products. Please be advised that federal law does not provide a legal pathway for marketing biological products that have been prepared outside the scope of an approved biologics license application (BLA).
Cerebrolysin, thymosin alpha, thymosin beta, BPC-157, LL-37, pentosan, Selank, and Semax were not nominated for inclusion on the 503A bulks list.
Your firm compounded drug products using (b)(4). Drug products compounded using (b)(4), and (b)(4) are not eligible for the exemptions provided by section 503A(a), because (b)(4), and (b)(4) are not the subject of an applicable USP or NF monograph, are not components of FDA-approved human drugs, and do not appear on the 503A bulks list.
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.
it appears you may have been compounding using the bulk drug substance piracetam. Drug products compounded using bulk piracetam are not eligible for the exemptions provided by section 503A(a), because piracetam is not the subject of an applicable USP or NF monograph, not a component of an FDA-approved human drug and does not appear on the 503A bulks list.
Required actions (5)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing if you have taken any specific steps to address any violations, or you may inform us that you do not intend to resume production of sterile drugs.
you should notify this office fifteen (15) working days prior to resuming production of any sterile drugs in the future.
Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA strongly recommends that if you decide to resume production of sterile drugs, your management first 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 processing expertise should assist you in conducting this comprehensive evaluation.
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