FDA 483 - Bentley Laboratories LLC - March 27, 2026

Between March 16 and March 27, 2026, the FDA inspected the manufacturing facility of Bentley Laboratories LLC in Edison, New Jersey. This inspection identified several significant violations in the production of over-the-counter (OTC) drug products. Key issues included a failure to perform mandatory identity testing on raw materials, instead relying on unverified supplier reports. The firm also failed to adequately test finished products for specific microbial contaminants like B. cepacia and neglected to investigate instances where products failed physical stability or microbial limit specifications. Significant data integrity concerns were noted, as electronic systems used for testing and weighing lacked audit trails and were not protected against the deletion or modification of records. Additionally, the company changed manufacturing processes without required re-validation, failed to document effective cleaning procedures for equipment, and did not properly investigate customer reports of allergic reactions. These observations were issued under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. Bentley Laboratories LLC is expected to address these deficiencies by implementing corrective actions and may submit a formal response to the FDA detailing their progress and any objections to the findings.