FDA sends Warning Letter to Canadian OTC Manufacturer

Recommendation

7/8 May 2024

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A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The firm manufactures hand sanitizer gel and burn and scar cream.

The document dated 27 March 2024 was published on the authority's website on 02 April 2024. The following violations were identified based on a review of records submitted in response to a request for records and other information:

• Failure to conduct adequate testing to verify the identity of incoming components used in drug products.
• The company did not demonstrate that it tested incoming lots of ethanol for methanol, which is used to manufacture the hand sanitizers for distribution in the United States.
• Inadequate testing of finished drug products for active ingredient content and impurities before release.
• Lack of validation of production processes.
• Failure to establish written procedures for production and process control.
• Incomplete batch production and control records, lacking essential details for each significant step in the manufacturing process, such as sampling information, actual and theoretical yield calculations, identification and quality approval signatures of the persons performing and directly supervising each significant step.

Additionally, two of the company's products were found to be unapproved new drugs due to claims made on their labels and website indicating intended uses as drugs for treatment and prevention of various conditions.

The FDA recommends engaging a qualified consultant to assist in meeting CGMP requirements if the firm intends to resume manufacturing drugs for the U.S. market.

The firm is given 15 working days to respond to the letter and specify actions taken to address the violations and prevent recurrence. Failure to do so may lead to further regulatory actions.

For further information, please read the complete Warning Letter to Bodywell Natural Skin Care Inc., published on the FDA website.