FDA Warns Creative Essences for Deficient Investigations and CAPA Management

The U.S. FDA has issued a Warning Letter to Creative Essences, Inc. (California, USA), citing serious violations of current Good Manufacturing Practice (CGMP) requirements. The agency highlighted repeated findings such as failure to identify root causes, implement effective corrective and preventive actions (CAPA), and expand investigations to assess broader product impact—indicating systemic quality control failures.

Key issues included the Quality Unit’s failure to investigate:

• Out-of-specification (OOS) results for an incoming API lot
• Microbial OOS results in the water system
• Stability failures (pH and viscosity) in a released batch

The FDA found the company’s investigations incomplete and lacking scientific justification, with unsupported CAPAs and no retrospective review. Additionally, a microbiological testing deviation revealed poor sampling practices and delayed corrective action due to “resource issues.”

The FDA advised hiring a CGMP consultant to assess and remediate systemic weaknesses, stressing that executive management bears ultimate responsibility for achieving and maintaining compliance.

20-10-2025