FDA WARNING_LETTER - ABBE Laboratories, Inc. - February 27, 2025

The FDA issued a warning letter to ABBE Laboratories, Inc. following an inspection of its Farmingdale, New York facility from February 24 to 27, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company’s over-the-counter (OTC) drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Major concerns included the company’s failure to conduct identity testing on raw materials. Specifically, ABBE Laboratories did not adequately test high-risk components like glycerin and propylene glycol for lethal contaminants such as diethylene glycol (DEG) and ethylene glycol (EG). Additionally, the company failed to maintain effective equipment cleaning procedures, lacking both documentation and validation studies for shared manufacturing tools. The FDA also noted a lack of process validation to ensure consistent product quality and poor oversight by the Quality Control unit, including incomplete batch records and a failure to perform annual product reviews since 2018. Notably, several of these issues were repeat violations from a 2018 inspection. To address these deficiencies, ABBE Laboratories must conduct a full risk assessment for products containing high-risk ingredients and provide immediate DEG and EG test results. The company is also required to implement a robust cleaning validation program, establish process performance qualifications for all marketed drugs, and overhaul its Quality Unit to ensure proper oversight and documentation. Failure to promptly correct these violations could result in regulatory action, including product seizures or legal injunctions.