Drugs

Multiple Violations Found in Sanitor Inspection

David McFarland

— 1 min read
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A 5/25-6/3 FDA inspection at Sanitor Corp., Stanton, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in the firm’s work manufacturing drug products to bleach or lighten the skin that FDA says are unapproved new drugs. An 11/29 Warning Letter says specific violations were: 

  •          failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
  •          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 exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records;
  •          failing to have an FDA approved application in effect for its drug products;
  •          failure of the labeling to bear a statement of identity with the established name and general pharmacological category or principal intended action; and
  •          registration listing violations.

The letter says the firm’s executive management oversight and control over the manufacture of drugs are inadequate. “Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance,” FDA says. “You should immediately and comprehensively assess your company’s manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

The agency reminds Sanitor that it is responsible for the quality of drugs it produces as a contract manufacturer regardless of agreements in place with product owners. It recommends that the company engage a consultant with, at minimum, appropriate CGMP expertise in overall quality risk management, data integrity, and investigations to assist it in meeting CGMP requirements.

Sanitor 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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