U.S. Manufacturer Faces FDA Warning Letter for Serious Quality Failures

In August 2024, the U.S. Food and Drug Administration (FDA) sent a Warning Letter to a U.S. manufacturer following an inspection that revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations. The letter, dated 19 August 2024, was published on 03 September 2024. It refers to an inspection of the firm's drug manufacturing facility in Floral Park, New York, conducted from 14 February to 01 March 2024.

Key Findings

The main findings can be summarized as follows:

• Failure to test raw materials and drug products for identity, purity, strength, and quality.
• Inadequate written procedures for production and process control.
• Lack of process validation to ensure consistent product quality.
• Insufficient cleaning and maintenance of manufacturing equipment, risking contamination.
• Poor employee adherence to validated procedures during manufacturing.
• Lack of proper batch record retention for traceability.
• Absence of scientifically sound sampling plans.

Details

The letter highlighted that the firm failed to establish scientifically sound sampling plans. In this context, the authority writes: "You failed to conduct any test to confirm the identity of incoming raw materials. For example, you stated sodium fluoride, which is the active ingredient in your Kaylaan Toothpaste Tablets with Fluoride, is not subjected to chemical analysis. Furthermore, you stated you rely on the supplier’s certificate of analysis (COA) in lieu of conducting your own testing."

The company was also found to have insufficient process validation measures, which are critical for ensuring that products consistently meet safety and efficacy standards. The FDA emphasized that the company must implement proper controls to guarantee the quality of their products, especially as they market drug products under the U.S. regulatory framework.

Furthermore, the company did not maintain equipment in a state of cleanliness that would prevent cross-contamination between different products.

The letter detailed that Kaylaan’s production lacked essential monitoring, and employees were not following validated written procedures for manufacturing, which could result in inconsistent quality across their product line. Additionally, the company did not retain batch records that would allow tracing any deficiencies back to specific batches, which is required to ensure accountability and traceability in drug production.

The FDA requested a comprehensive corrective action plan within 15 working days to address these deficiencies and warned of possible legal consequences if compliance is not achieved.

For more information, please see the complete Warning Letter to Kaylaan LLC on the FDA's website.