Institute of Good Manufacturing Practices India®

Inadequate Quality Unit, Laboratory Controls, Sampling Plans, and Stability Program: FDA Warning Letter to Clientele, Inc.


The U.S. FDA (Food and Drug Administration) sent a Warning Letter to Clientele, Inc. The firm produces OTC topical drug products that include sunscreen active ingredients and pain-relieving active ingredients. During an inspection from 3 to 7 February 2020, significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals were observed.

According to the FDA, the company's Quality Unit (QU) did not provide adequate oversight for the OTC drug products' manufacture. 

It also failed to validate the processes used to manufacture the drug products adequately. 

There were insufficient Laboratory Controls.

No Adequate Stability Data was Available during the inspection.

The company has already committed a statement to cease manufacturing drug products and deregister the facility as a drug manufacturer.