FDA Posts CDER Compliance Records and Inspection Resources

What happened

The FDA CDER FOIA Electronic Reading Room page lists frequently requested or proactively posted compliance records for drugs. Its table identifies untitled letters and other correspondence by record date, FEI number where shown, firm, record type, country, and posting date. Listed firms include Neeyaan, Formulated Solutions, Port Jervis Laboratories, Chemspec Chemicals, Aptar Radolfzell, Amazon.com, Industria Farmaceutica Nova Argentia, Laurus Synthesis, Nectar Lifesciences, Shandong Boyuan Pharmaceutical, Silliker/Merieux NutriSciences, and Valisure. The page also directs users to FDA databases for inspections, drug-promotion untitled letters, Forms FDA 483, and establishment inspection reports. Content is marked current as of August 18, 2026.

Why it matters

From a GMP and pharmaceutical manufacturing perspective, the page provides a centralized route to publicly available compliance records and related inspection resources. Manufacturers and quality functions may use these records to monitor FDA compliance activity involving drug firms and locate inspection documentation. However, the source page only catalogs and links records; it does not describe underlying observations, deficiencies, corrective actions, or regulatory requirements, so GMP conclusions require review of the linked documents.

Key topics: CDER compliance record listings, Untitled letters and other correspondence, FDA inspection and FOIA resources

Source: U.S. Food and Drug Administration (FDA)