December is generally a slow time when it comes to posting of FDA Warning Letters.

Nevertheless, on Dec. 3, FDA issued a Warning Letter to over-the-counter manufacturer Clientele, Inc. following a Feb. 3-7 inspection of the company’s Sunrise, FL facility.  The company’s products generally consist of skincare topicals and cosmetics.

Following the inspection, the resulting FDA form 483 featured five observations.

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Observation 1 pointed to failure to follow procedures “applicable to the quality control unit,” noting that personnel lacked the cGMP knowledge to oversee cGMP systems. 

Specific observations included:

  • Failure to ensure completion of product testing prior to distributing products
  • Lack of a supplier qualification program
  • Failure to perform stability testing and potency testing
  • Data integrity failures pertaining to batch records and raw ingredient specification records

Other observations involved laboratory controls and cleaning validation issues.

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