Milford, Mass. — Nitto Avecia, a contract development and manufacturing organization specializing in oligonucleotide therapeutics, said the U.S. Food and Drug Administration classified its latest inspection as No Action Indicated.
The result followed an unannounced six-day routine current Good Manufacturing Practice inspection of the company’s Milford facility, which resulted in no FDA Form 483 observations.
The inspection marks the third consecutive FDA review of a Nitto Avecia facility to end with zero Form 483 observations and an NAI classification.
The company’s Cincinnati, Ohio, facility received the same result in 2024, followed by its Irvine, California, facility in 2025 and the Milford facility in 2026.
Nitto Avecia said the results demonstrate the consistency of its quality systems across its U.S. operations and its focus on regulatory compliance.
FDA cGMP inspections of pharmaceutical quality systems use a six-system model covering quality, facilities and equipment, materials, production, packaging and labeling, and laboratory controls. A full inspection generally covers at least four of the six systems, including 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 of 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.”
