FDA Warning Letter: Deficiencies in API / Finished Drug Product Testing and Stability Program

The United States Food and Drug Administration (FDA) has recently published a Warning Letter to Furley Bioextracts SDN BHD, a manufacturer of over-the-counter (OTC) drug products located in Malaysia. The FDA has reviewed the records the company submitted in response to a request from November 2020. 

The Warning Letter summarizes significant violations of current good manufacturing practices (CGMP) concerning finished drug product testing, identity testing of active pharmaceutical ingredients (APIs), and stability testing. There are various overlaps in content with a Warning Letter to Natural Beauty Care Pty Ltd, an Australian manufacturer of OTC drug products, which you could recently read about.

Key Deviations

The violations mainly concern the following points:

• Finished drug product testing: According to the FDA, Furley Bioextracts SDN BHD did not conduct adequate finished drug product testing on drug products shipped to the United States. This concerns, in particular, testing for the identity and strength of the active ingredient menthol in one of the OTC drug products (PainFix Relief Gel).
• Identity testing of APIs: The Warning Letter states that based on the records and information the company provided, it could not be demonstrated that testing of incoming lots of the API used to manufacture the OTC drug products to determine their identity was performed. The company relied solely on vendor certificates of analysis (COA).
• Stability testing: The company failed to provide adequate stability data to demonstrate that the chemical properties of the OTC products remain acceptable throughout the labeled expiry period.

Further Deficiencies and Recommendations for Improvement

In addition, the Warning Letter adresses the following points:

• Unapproved new drug and misbranding violations: According to the FDA, PainFix Relief Gel is an unapproved new drug and a misbranded drug. Introduction or delivery for introduction of such products into interstate commerce is prohibited.
• Process controls: The company did not prepare a process validation protocol or qualify the filling equipment. The batch production record did not include documentation of each significant step in the manufacturing process.
• Quality systems: The FDA considers the quality system to be inadequate.
• CGMP consultant: The FDA strongly recommends engaging a consultant to assist the firm in meeting CGMP requirement.

To view the complete list of violations and the conclusion drawn by the FDA, please see the Warning Letter to Furley Bioextracts SDN BHD published on the FDA's website.