The US Food and Drug Administration (FDA) has issued a warning letter to dietary supplement manufacturer Nutratech LLC, citing multiple current Good Manufacturing Practice (cGMP) violations and a labelling deficiency that rendered one product misbranded under US regulations.
The warning follows an FDA inspection of the company's manufacturing facility in Sheridan, Indiana, conducted between September and October 2025.
According to the agency, the inspection identified a series of deficiencies relating to manufacturing controls, sanitation practices, quality systems and documentation.
In its warning letter, the FDA said the findings were significant enough for dietary supplements manufactured at the facility to be considered adulterated under the Federal Food, Drug, and Cosmetic Act due to non-compliance with dietary supplement cGMP requirements.
Among the observations outlined by the agency were inadequate sanitation procedures, insufficient maintenance of manufacturing equipment and facilities, incomplete batch production records and failures to establish appropriate finished-product specifications.
FDA inspectors also cited deficiencies in complaint handling procedures and quality control oversight.
The agency further stated that one dietary supplement product was misbranded after failing to declare a major food allergen on its label, raising additional concerns about regulatory compliance.
While Nutratech submitted responses outlining planned corrective actions following the inspection, the FDA said many of the proposed measures lacked sufficient supporting documentation to demonstrate they had been fully implemented.
The agency requested that the company provide evidence of completed corrective actions and warned that failure to adequately address the violations could result in further enforcement action.
The warning serves as a reminder of the FDA's continued focus on manufacturing quality within the dietary supplement sector.
In recent years, the agency has placed increasing emphasis on companies maintaining robust quality management systems, validated manufacturing processes and comprehensive documentation to ensure products consistently meet regulatory requirements.
For contract manufacturers in particular, the letter highlights the importance of demonstrating not only that corrective actions have been planned, but that they have been effectively implemented and verified.
As regulatory scrutiny of dietary supplement manufacturing continues, quality systems, record-keeping and allergen controls remain central to maintaining compliance and protecting consumer confidence.
Nutraceutical Business Review contacted Nutratech for comment ahead of publication but had not received a response at the time of publishing.
