Aegle Nutrition Receives Closeout Letter from the FDA

Share Article

Aegle Nutrition successfully closes out the FDA's 483 warning letter from July 2018.

We are pleased with this outcome for the continual growth and improvement our organization

Aegle Nutrition, an industry leader and manufacturer of liquid dietary supplements, announced it received a closeout letter from the Food and Drug Administration (FDA). The letter, dated August 4, 2020, successfully closes out the FDA’s 483 Warning Letter received in July 2018. The company said that the receipt of the letter also signals the completion of a 24-month initiative to expand and enhance quality management systems after receiving the 483.

In addition to the improvements in quality management systems, Aegle Nutrition reorganized its Quality Department to ensure continued regulatory compliance and continuous improvements. Dr. Shantha Sithambaram, Director of Quality, now leads Aegle’s quality and regulatory affairs efforts.

“We are pleased with this outcome for the continual growth and improvement our organization,” said Aegle President John Ramsey. “It underscores our commitment to maintaining a compliant site and superior quality management system, and to delivering products that are of the highest quality.”

To view the official closeout letter, please visit the FDA website here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aegle-nutrition-llc-546966-08042020

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Marissa Amaya
Visit website

Media