Two Companies Get Warning Letters Over Misbranded Drugs, Product Specification

Ajes Pharmaceuticals and Positive Power Nutrition have been hit with warning letters after the FDA conducted inspections.

Positive Power Nutrition got a warning letter for its 11 products due to claims made, including claims that the products help the body heal from varicose veins; protect against cardiovascular disease; fight bone loss, chronic fatigue, depression, constipation, ringing in the ears, and pernicious anemia; and are found to aid in the healing of gastritis, liver disorders, asthma, and anemia.

The products fail to bear adequate directions for their intended use, and there is no data to prove that the claims made by Positive Power Nutrition for their medications are true.

Ajes Pharmaceuticals failed to establish product specifications for the identity, purity, strength, and composition of its finished batches of dietary supplements.

In its response Ajes stated that it had taken measures to ensure finished product testing and to ensure specifications were met for identity, purity, strength and composition, but did not provide complete finished product specifications and acceptance criteria for the products.

In addition, Ajes did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements. Ajes’ response also does not contain sufficient information to determine if the products meet its specifications.

The CCDS serves as the basis for prescribing a medication but also for global advertising and promotional activities. In some countries, notably the U.S., promotional claims that do not conform to approved-labeling can render the product misbranded. It’s high time you sharpened your CCDS-writing skills. Order our Perfecting Your Company Core Data Sheets webinar cd to help you do just that.