OTC manufacturers are warned about protocol failures

OTC manufacturers are warned about protocol failures

On Behalf of | May 9, 2022 | Personal Injury

Over the counter (OTC) drug manufacturers are trained to make products that are safe for the entire public without requiring prescriptions from medical providers. In California and across the country, a few have been warned for failing to adhere to appropriate standards for investigations, product testing and validation processes.

Oversight of OTC manufacturing

Recently, two OTC manufacturers were issued warnings for multiple violations for this year and previous years from the Food and Drug Administration. They received good manufacturing practice violations for failing to make investigations properly, poor testing for product ingredients and lacking validations in manufacturing processes.

Both companies manufacture skincare products, including hydroquinone creams, sunscreens and hand sanitizers. One company was cited for poor testing practices for certain pharmaceutical ingredients. Proper testing is necessary to ensure that the product ingredients are manufactured correctly for use in drugs.

Another claim from the FDA was the failure to validate manufacturing processes and qualify equipment, which are necessary to detect and prevent product defects before they occur. The equipment used to manufacture drug and cosmetic products was not cleaned and increased the risk of cross-contamination. One company did not adhere to process performance qualification studies that are designed to maintain high levels of production quality.

FDA procedures to ensure product safety

The FDA issues warning letters to manufacturing companies that repeatedly fail to monitor the manufacturing processes of their drugs. Investigators uncover all types of problems from lack of validation to improper testing and cross-contamination. Without the government’s oversight, countless more consumers would suffer from injuries, widespread product recalls would occur and more manufacturers would be sued in product liability cases.