FDA Warning Letter to South African OTC Drug Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated 21 November 2024 for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The facility in question, located in South Africa, is registered as a manufacturer of over-the-counter (OTC) drug products. The authority has reviewed the records the company submitted in response to a formal request for records and other information.

Key Violations

The observations include:

• Lack of Adequate Component Testing: The company failed to perform adequate identity testing for incoming raw materials used in drug production. Instead, they relied on rudimentary assessments such as appearance and odor checks, which, of course, do not meet FDA requirements for ensuring the quality, identity, and purity of components.
• Inadequate Quality Control: The firm's quality control procedures do not sufficiently ensure that finished drug products meet established specifications. The company stated that they only perform pH, viscosity, and “organoleptic comparison” testing. This raises concerns about the safety and efficacy of the drugs manufactured at the facility.
• Lack of Stability Testing: The company did not demonstrate that their products remain acceptable throughout their assigned shelf life. The FDA noted that the stability program omitted essential tests, such as potency and assay evaluations.
• Absence of Process Validation: The manufacturer had no process validation procedures or process validation studies in place.

Regulatory Consequences

Due to these lapses, the company’s products were deemed "adulterated" under the Federal Food, Drug, and Cosmetic Act. This classification indicates that the products were not manufactured in compliance with CGMP, potentially posing risks to consumers. The company was placed on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs") on 18 November 2024.

The FDA has outlined specific corrective actions, and the company is required to submit a detailed response to the FDA, outlining their plans to address these deficiencies and prevent recurrence.

For more details, the full Warning Letter to Catwalk Cosmetic Laboratories Pty Ltd. can be accessed on the FDA's website.