Drugs

CGMP Violations at Vi-Jon Facility

David McFarland

— 1 min read
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A 10/4-10/13/21 FDA inspection at the Vi-Jon drug manufacturing facility in St. Louis, MO, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/31 Warning Letter says specific violations were: 

  •          failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
  •          failing to establish and follow adequate written procedures for cleaning and maintenance of equipment;
  •          failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
  •          failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in the master production and control records or other records. 

The letter says the firm’s responses to the inspection observations were inadequate. It also says the cosmetic products that the firm manufactures are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

FDA says Vi-Jon “has a history of investigations that do not appear to adequately determine the root cause of the microbial contamination nor implement effective corrective and preventive actions. Further, there is inadequate cleaning and/or sanitization of equipment used in the manufacturing of cosmetics.”

The violations demonstrate a failure of the firm’s executive management to exercise proper oversight and control over the manufacture of drugs, FDA says. It recommends that Vi-Jon retain a qualified consultant to assist it in meeting CGMP requirements.

The firm was told to correct any violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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