Pharmaceutical

Dietary supplement maker warned by FDA

dietary supplements pills probiotics Dietary supplement maker warned by FDANature com Inc., a California-based dietary supplement company, was slapped with a Food and Drug Administration (FDA) warning letter for not keeping track of the weights and measurements of each finished package or which scales or scoops were cleaned, rendering the products in violation of the Federal Food, Drug and Cosmetic and the Current Good Manufacturing Practice regulations for dietary supplements.

The problems were identified during an FDA inspection of the company’s manufacturing facility. During that inspection the FDA found that the Naturecom did not prepare or follow a master manufacturing record. Once this is established for dietary supplement products that the company packages, it must establish specifications to ensure the quality of the supplements and that the supplement is packaged and labeled as specified in the master manufacturing records.

“And, you must fill, assemble, package, label and perform other related operations in a way that ensures the quality of the dietary supplement and that dietary supplement is packaged and labeled as specified in the master manufacturing record,” the warning letter states.

The FDA also called out the company for failing to include in its batch production records equipment used in producing the batch, the date and time of maintenance and sanitizing, the weight or measure of each finished package, the date weighing and packaging occurred, and the quantity of packaging materials used.

Naturecom responded to the FDA’s initial concerns on Dec. 18, 2016, but “we were unable to evaluate the adequacy of your corrective action,” the FDA said. The company was also chided for misbranding its dietary supplements because of labeling issues.

“Additionally, we have the following comment. We acknowledge that you have voluntarily recalled your products with 1,3-dimethylamylamine, also known as DMAA or geranium extract. Please provide this office with the status of your activities of this on-going recall and any plan you have to prevent this from recurring,” the letter stated.

DMAA works like a stimulant that can cause side effects such as rapid heartbeat, increased blood pressure, heart attack and stroke. The ingredient is banned in the U.S.

Sources:
FDA Warning Letter
Law360