Nitto Avecia, a leading contract development and manufacturing organization (CDMO) specializing in oligonucleotide therapeutics, today announced that the U.S. Food and Drug Administration (FDA) classified their recently completed inspection as No Action Indicated (NAI). This highly favorable result follows an unannounced six-day routine regulatory current Good Manufacturing Practice (cGMP) inspection of its Milford, Massachusetts facility, resulting in zero FDA Form 483 observations.
The result marks the third consecutive FDA inspection of a Nitto Avecia facility to conclude with zero Form 483 observations and NAI classifications. The company’s Cincinnati, Ohio facility achieved this inspection result in 2024, followed by its Irvine, California facility in 2025 and now its Milford, Massachusetts facility in 2026. Together, the results demonstrate the consistency of Nitto Avecia’s quality systems across its U.S. operations and the company’s longstanding commitment to quality and regulatory compliance.
The FDA cGMP inspections of the Pharmaceutical Quality System (PQS) are conducted using a six-system model encompassing Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Controls. These systems collectively provide a framework for evaluating the state of control within pharmaceutical manufacturing operations. A full inspection would cover at least four of the six systems, one of which must be the Quality System.
“At Nitto Avecia, we strive every day to meet and exceed rigorous quality standards and client expectations, enabling our biotechnology and pharmaceutical partners to confidently rely on the quality of the active pharmaceutical ingredients we manufacture as they advance innovative therapies,” said Tammy Cooper, President at Nitto Avecia. “We are exceptionally proud that all three facilities have now completed their most recent FDA inspections with an NAI classification. Achieving this outcome across multiple sites demonstrates the strength and consistency of our quality systems and, most importantly, reflects the dedication, expertise, and commitment demonstrated every day by our employees across Quality, Development, and Operations.”
About Nitto Avecia
Nitto Avecia, a Nitto Denko Group company, is a leading oligonucleotide CDMO delivering development and manufacturing solutions from preclinical development through commercial supply. Nitto Avecia offers expertise in analytical development, process development, cGMP drug substance manufacturing, process performance qualification (PPQ) and quality control, supporting oligonucleotide modalities and chemistries.
Nitto Avecia partners with biotechnology and pharmaceutical companies to accelerate the development and commercialization of innovative nucleic acid therapeutics. For more information, visit www.avecia.com.
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