The Food and Drug Administration (FDA) is an agency within the US Department of Health and Human Services that is responsible for protecting and promoting public health through control and supervision of food and medical products (among other things). They are responsible for enforcement of the Federal Food, Drug, and Cosmetic Act including published monographs from the United States Pharmacopeia (USP) and the National Formulary (NF) through industry regulation and auditing of registered companies.
Atlantic Analytical Laboratory FDA registration number: 2246907
Since the establishment of our fully cGMP-compliant laboratory in 2004, AAL has hosted four unannounced FDA audits (Dec 2009, Aug 2011, Oct 2013, Feb 2017). No FDA Form 483’s were issued after any of these multiple-day audits.
We welcome pharmaceutical customer cGMP audits so that we can continually strengthen our quality system and capabilities for FDA compliance testing.