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.
Interested in knowing more about the specific deficiencies in these areas? Want to know who inspected the site? Test drive our Enforcement Analytics platform to get answers to those questions and more!
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