Drugs

Multiple Violations at Guyer Institute

David McFarland

— 2 min read
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A 10/13-10/29/20 FDA inspection at Advanced Neutriceuticals, doing business as Guyer Institute of Molecular Medicine, Indianapolis, IN, found multiple violations of laws and regulations. An 11/10 Warning Letter says the firm failed to meet conditions for exemption from certain provisions of the Federal Food, Drug, and Cosmetic Act and had serious deficiencies in its practices for producing sterile drug products, putting patients at risk.

The letter says agency investigators noted the drug products were prepared, packed, or held under insanitary conditions and that the company did not receive a valid prescription for individually-identified patients for a portion of the drug products it produced.

Current Good Manufacturing Practice (CGMP) regulation violations noted were: 

  •          failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
  •          failing to ensure that manufacturing personnel wear clothing appropriate to protect drug products from contamination;
  •          failing 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;
  •          failing to establish a system for monitoring environmental conditions in aseptic processing areas;
  •          failing 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;
  •          failing to establish written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
  •          failing 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; and
  •          failing to retest or reexamine components, as appropriate, for identity, strength, quality, and purity and failure of the company quality control unit to approve or reject components. 

The letter also says the firm does not have FDA-approved applications on file for the ineligible drug products it compounded and that those ineligible products are misbranded.

FDA says it reviewed the firm’s response to the FDA-483 presented after the inspection and acknowledges that the company voluntarily ceased sterile production while corrective actions were implemented and initiated a recall of all compounded sterile products within expiry due to a lack of sterility assurance.

Some of Guyer’s proposed corrective actions related to the insanitary conditions appear adequate, FDA says, while others cannot be fully evaluated because Guyer did not include sufficient information or documentation.

“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,” the Warning Letter says. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug processing experience should assist you in conducting this comprehensive evaluation.”

Guyer was told to take prompt action to correct all violations if it intends to resume production of sterile drugs. In this event, the letter says, “please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.”

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