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Posted April 11, 2013

Maker of Workout Booster Warned For Manufacturing Violations

On March 5, 2013, the FDA issued a warning letter to Primarch Manufacturing, Inc. following a facility inspection which found the company's products, including NO Holds N-O Fruit Punch, to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements.

These violations include failure to establish specifications for any of the dietary supplements the company manufacturers, including NO Holds N-O Fruit Punch, failure to prepare and follow a written master manufacturing (MMR) record for each unique formulation of dietary supplement, and storing reserve samples of each lot of dietary supplements in plastic bags rather than in the container-closure system in which supplement is distributed, as required by federal regulations.

The FDA also stated that Primarch's attempt to correct these violations was inadequate. The company has 15 days to respond to the agency and explain what steps it will be taking to address these issues.

NO Holds N-O Fruit Punch contains nitrous (di-arginine malate, L-arginine, arginine alpha ketoglutarate powder, L-arginine), citrulline malate, L-glutamine, L-tyrosine and L-taurine and is promoted as a workout booster.

See's Review Article on Nitric Oxide Supplements For Bodybuilding and Athletic Performance and Reviews of Muscle Enhancers and L-Arginine Supplements for tests of related products.

For more information about this warning letter, use the link below.