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FDA Warning Letter Explorer
FDA warning letter · Drugs

Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicine

Issued · Posted by FDA

FDA published a close-out letter on Mar 17, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Passage 3

Your firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).

Passage 4

Your firm failed to clean and sterilize and process, where indicated by the nature of the drug, container closures to remove pyrogenic properties to assure they are suitable for their intended use (21 CFR 211.94(c)).

Passage 5

Your firm failed to establish a system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Passage 6

Your firm failed to have buildings used in the manufacture, processing, packing, or holding of drug products of a suitable size, construction and location to facilitate cleaning, maintenance, and proper operations (21 CFR 211.42(a)).

Passage 7

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 8

Your firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch (21 CFR 211.188(b)).

Passage 9

Your firm failed to retest or reexamine components, as appropriate, for identity, strength, quality, and purity and your quality control unit failed to approve or reject components (21 CFR 211.87).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 200.10(b)
  • 21 CFR 201.115
  • 21 CFR 210.1(b)
  • 21 CFR 211.113(b)
  • 21 CFR 211.28(a)
  • 21 CFR 211.94(c)
  • 21 CFR 211.42(c)(10)(iv)
  • 21 CFR 211.42(a)
  • 21 CFR 211.100(a)
  • 21 CFR 211.188(b)
  • 21 CFR 211.87