FDA 483 - Atlantic Analytical Laboratories LLC - March 17, 2026

From March 2 through March 17, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of Atlantic Analytical Laboratories LLC, a contract testing laboratory located in Whitehouse, New Jersey. The inspection, issued to CEO Bruce J. Gollob, identified significant deficiencies in the facility’s quality control procedures. The primary violation involved the firm"s failure to verify that their analytical testing methods were suitable for actual use. Specifically, investigators found that the laboratory had not completed required verification studies for several standardized methods used to test product potency and impurities. These omissions spanned multiple product lots and included failures to validate specific chromatography and impurity testing protocols. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these findings indicate that the laboratory"s testing results may not be consistently reliable. Although this document does not represent a final agency determination, the company is required to address these observations. Atlantic Analytical Laboratories must either discuss their corrective action plans with the FDA or submit a formal written response outlining the steps they will take to ensure all testing methods are properly validated and compliant with safety standards.