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.
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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