Drugs

Multiple Clinical Resolution Laboratory Violations

David McFarland

— 1 min read
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A 4/6-4/27/21 FDA inspection at the Clinical Resolution Laboratory drug manufacturing facility in Brea, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in its production of finished drugs. A just-released 3/1 Warning Letter says specific CGMP violations were: 

  •          failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
  •          failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
  •          failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release; and
  •          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. 

The letter says FDA cited similar CGMP observations in a 5/8-5/15/18 inspection and the company proposed specific remediation for the observations in its response. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says. The agency also says the firm’s 5/18/21 response to the latest FDA-483 was inadequate because it did not provide sufficient detail or evidence of corrective actions to bring the operations into compliance with CGMP.

The letter reminds Clinical Resolution that it is responsible for the quality of its drugs regardless of any agreement in place with contract manufacturing organizations.

Because the firm’s quality systems are inadequate and because it failed to correct repeat violations, FDA strongly recommends that it retain a qualified consultant to assist it in meeting CGMP requirements.

The letter also cites Clinical Resolution for producing several unapproved new drugs that are misbranded.

The firm was told to correct the violations promptly and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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