Bentley Laboratories LLC – FDA Warning Letter, Mar 27, 2026

On September 17, 2026, the FDA issued a Warning Letter to Bentley Laboratories LLC following an inspection of its Edison, New Jersey, manufacturing facility conducted from March 16 to 27, 2026. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations and the Federal Food, Drug, and Cosmetic Act, resulting in the firm’s products being classified as adulterated and misbranded. Key violations included a failure to thoroughly investigate out-of-specification laboratory results and stability failures. The firm also failed to perform mandatory identity testing on raw materials, notably neglecting to screen high-risk ingredients for hazardous contaminants like diethylene glycol and ethylene glycol. Furthermore, Bentley Laboratories failed to adequately validate manufacturing and cleaning processes, providing insufficient assurance against cross-contamination. The FDA also designated Geologie Acne Control Body Wash and Perricone MD Acne Relief Maximum Strength Spot Gel as unapproved new drugs because they contained active ingredients not permitted by the applicable over-the-counter monograph. Bentley Laboratories has suspended production of its drug products. To resolve these issues, the company must hire a qualified independent consultant to perform a comprehensive audit and implement a remediation plan. Required actions include conducting a full risk assessment for distributed products, establishing robust vendor qualification programs, and submitting detailed corrective action plans to the FDA before resuming manufacturing operations. Failure to address these systemic quality unit failures may lead to further legal action, such as product seizures or injunctions.