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

In August 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a U.S. manufacturer, Kaylaan LLC, after an inspection uncovered significant violations of Current Good Manufacturing Practice (CGMP) regulations. The letter, dated August 19, 2024, and published on September 3, 2024, followed an inspection of the company's drug manufacturing facility in Floral Park, New York, conducted from February 14 to March 1, 2024.

Key findings included:

- Failure to test raw materials and drug products for identity, purity, strength, and quality.

- Inadequate production and process control procedures.

- Lack of process validation to ensure product consistency.

- Insufficient cleaning and maintenance of equipment, increasing contamination risks.

- Non-adherence to validated manufacturing procedures by employees.

- Incomplete batch record retention, preventing traceability.

- Absence of scientifically sound sampling plans.

The FDA highlighted the firm's failure to test raw materials, relying instead on supplier certificates without conducting its own analyses. The agency demanded a corrective action plan within 15 days and warned of potential legal consequences for non-compliance. For further details, see the full Warning Letter on the FDA website.