Aldevron Breakthrough Blog
Aldevron Successfully Completes 2024 FDA Inspection
April 2, 2025 by Aldevron
Third successful inspection since 2021
Regulatory inspections are designed to show therapeutics researchers and manufacturers that their service providers meet the most stringent requirements for safety and efficacy. Passing these audits, which can be scheduled or unannounced, show how the capabilities of a facility measure up to those requirements.
With that in mind, we are pleased to announce that Aldevron successfully completed another FDA inspection in November 2024. This unannounced Level 1 surveillance inspection found no observations, marking our third successful regulatory inspection since 2021 and our second FDA inspection resulting in No Actions Indicated (NAI).
These successful inspections reaffirm that we have an ongoing commitment to quality and continuous improvement.
Aldevron’s inspection history
- November 2021: First FDA inspection, resulting in NAI
- June 2024: Inspection by the Government of Upper Bavaria, leading to our first cGMP certificate
- November 2024: Second FDA inspection, resulting in NAI
Why it matters to our clients
- Quality Assurance: The inspection confirms that Aldevron's processes meet the stringent requirements of the FDA's cGMP rating, ensuring high-quality products. Our clients can trust that their products are manufactured to the highest standards.
- Reliability: Clients can rely on our consistent compliance with regulatory standards, knowing we have a proven track record of successful inspections. This reliability is crucial for maintaining the integrity of their supply chains.
- Expertise: Our successful track record highlights our expertise and dedication to maintaining high standards. Clients benefit from our deep knowledge and experience in navigating complex regulatory environments.
- Safety: Ensuring the quality and safety of pharmaceutical products benefits end users, and provides peace of mind to clients and patients alike. This is particularly important in the pharmaceutical industry, where product safety is paramount.
As a trusted partner for leading pharmaceutical and scientific organizations, Aldevron is committed to quality and continuous improvement, ensuring that we continue to meet and exceed the expectations of our clients and regulatory bodies.
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Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin.