Being an FDA-approved CDMO partner means more than having GMP certification: it requires demonstrable inspection history, facility readiness for U.S. regulations, and consistent regulatory compliance. For your programs to succeed in the U.S., you must partner with a CDMO that has passed FDA inspections, has no unresolved warning letters, and maintains audit-ready quality systems. Key indicators include recent FDA audits, visible inspection reports, validated critical equipment, and the capability to support IND, NDA/ANDA, or BLA filing. These are not optional—they are foundational to minimizing risk, securing market authorization, and ensuring supply chain reliability.

Inspection History & Regulatory Track Record

You should examine whether the CDMO has undergone FDA inspections (pre-approval inspections, surveillance, post-approval facility audits) and whether any Form 483 observations were issued. It is crucial to establish whether previous observations were addressed with corrective actions and whether the facility has any outstanding regulatory letters. For example, some CDMOs report over 40 FDA inspections at certain sites, with many inspections resulting in no Form 483 findings. This level of regulatory transparency gives you confidence in their stability and compliance.

Facility & Technical Capabilities for FDA Compliance

As your FDA-approved CDMO partner, the facility must meet U.S. expectations for cleanroom classification, environmental controls, containment (if applicable), validated utilities (water, HVAC, clean steam), and equipment qualification. You should verify that manufacturing lines are designed to handle relevant dosage forms under U.S. regulatory guidelines, that the facility has automation or digital control systems that maintain audit trails, and that it can produce both clinical and commercial scale batches to the standards expected by the FDA. These capabilities reduce risks in transfer and commercialization phases.

Quality Systems, Data Integrity & Documentation Readiness

For a CDMO to truly qualify as FDA-approved in practice, their quality systems must enforce data integrity, CAPA effectiveness, validated analytical methods, and stringent documentation practices. You should ask for sample batch records, deviation trend reports, method validation data, cleaning validation logs, and evidence of timely corrective actions. These items demonstrate not just compliance, but the operational maturity needed to support your regulatory filings without significant delays.

Regulatory Support & Filing Experience

Your FDA-approved CDMO partner must have experience helping clients with U.S. regulatory submissions: INDs, NDAs, ANDAs or BLAs. You must confirm they understand FDA’s expectations on CMC documentation, impurity profiling, stability data requirements, and labeling. Also important is whether they have collaborated in Pre-Approval Inspections (PAIs) and responded successfully. This experience greatly reduces the risk of regulatory setbacks or queries that can delay your product launch.

Operational Transparency & Sponsor-CDMO Collaboration

A genuine FDA-approved CDMO partner maintains open communication, makes audit reports accessible, aligns on timelines, and involves sponsors in key milestones. As a sponsor, you should insist on regular status meetings, shared dashboards, visibility into audit findings, supply chain sourcing data, and escalation paths for delays or quality issues. Such collaboration prevents surprises and ensures that both you and the CDMO are acting toward the same regulatory and market objectives.

How Lianhe Aigen Aligns with Being Your FDA-Approved CDMO Partner

Lianhe Aigen has undergone multiple regulatory inspections, with recent audits confirming compliance with FDA expectations for APIs without unresolved major observations. Our facilities include equipment qualification, validated utilities, data systems with audit trails, and experienced regulatory affairs teams who have supported IND, NDA/ANDA filings for clients. If you seek an FDA-approved CDMO partner, you can request Lianhe Aigen’s inspection history, sample master validation reports, and audit/response documentation. For partnership details and capability verification, see Lianhe Aigen and contact via our contact page.