Benchmark Medical, Salt Lake City, Nov. 3 (Denver).

FDA inspected the drug manufacturing facility April 10-13, and determined that Benchmark's skin-protectant products--Derma Shield, Derma Plus and Derma Med--met the criteria for new drugs for which no NDAs had been filed. This determination was based on therapeutic claims made in the products' labeling, such as, "helps prevent and temporarily protects chafed, chapped, cracked or wind-burned skin"; "becomes an invisible protectant that actually bonds to the skin and helps protect it"; and, "prevents harmful substances from penetrating the skin and entering the bloodstream."

FDA noted that not only did the company not have an NDA for the aforementioned products, it had not established that the products were recognized as safe and effective for their intended uses.

During the inspection, the FDA investigator also observed deviations from current GMPs for human drug products. For example, the firm failed to provide an air break, or other mechanical device, between the sewer and the deionized water tank to prevent back-siphonage; and, the water line from the deionized water tank to the product-mixing kettles was constructed in such a manner that the piping allowed standing water to accumulate between drug product batches.

In addition, FDA said Benchmark failed to conduct identity testing of raw materials, its batch records were incomplete, and it had failed to develop a written testing program to test the stability characteristics of drug products to determine appropriate storage conditions and expiration dates. NDA, E-M, QC/QS, Stab, Ster; Doc. 14022W