Drugs

Firm Compounding Unapproved Domperidone Product: FDA

David McFarland

— 2 min read
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A 4/13-4/17/15 FDA inspection at Innovative Compounding Pharmacy, Folsom, CA, found that the pharmacy was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it produced, was producing domperidone drug products that were not the subject of an appropriate monograph or a component of an FDA-approved drug product, and had serious deficiencies in producing sterile drug products. A just-released 6/20 Warning Letter from the agency’s San Francisco District Office says the inspection was conducted due to a complaint received about an adverse event reportedly experienced by a patient who received a domperidone product prepared by the company.

The letter says that any drugs compounded without valid prescriptions for individually-identified patients and any compounded drug products using domperidone are not entitled to exemptions granted to some compounded drugs under the Federal Food, Drug, and Cosmetics Act.

The letter says that agency investigators noted that drug products in the facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions in which they may have become contaminated with filth or rendered injurious to health, causing the products to be adulterated under the law.

Current Good Manufacturing Practice violations observed at the facility included: 

  •          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;
  •          aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions;
  •          aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
  •          aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
  •          failing to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups;
  •          failing to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination; and
  •          failing to have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product.

The firm’s planned corrective actions appear to be inadequate, the letter says, to correct the observed insanitary conditions and GMP violations. “FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems,” it says. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.”

Innovative Compounding was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.

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