Federal Judge Issues Consent Decree for OTC Tennessee Drug Manufacturer

Federal Judge Issues Consent Decree for OTC Tennessee Drug Manufacturer

October 23rd, 2018 // 9:56 pm @

A federal court has issued an order to an over the counter drug company in Tennessee to cease the sale of OTC products until such time it is compliant with the FD&C Act. According to CDER, Americans both deserve and expect high quality OTC drug products. Although the company in question was given several warnings, Keystone Laboratories in Memphis put customers at risk by violating cGMP standards, which included not providing adequate instructions for use on its labels.

The consent decree of permanent injunction was issued in October 2018 after it was determined that Keystone Labs was distributing hair and skin care products that did not meet quality standards. For example, their drug products were not processed, manufactured, packed or held per cGMP standards. They did not investigate contamination sources that were found in some products. And, they failed to ensure drug products met specifications before they were sold to customers. Some drugs were misbranded because product labels did not have proper directions.

The consent decree states the firm must cease operations until all corrective actions are done. This includes hiring an independent expert to inspect its drug manufacturing facility and to ensure the firm is in full compliance with the FD&C Act. It also may not operate until it fully implements and runs a complete quality control system and is authorized by FDA to resume business.

FDA issued a warning letter to the company in 2013 for similar complaints. The warning letter noted that wooden sticks that were used in processing and cardboard used to cover product during processing could lead to contamination. There also were deep scratches and rust in vessels that were used to measure and mix drug products. Equipment and utensils had visible filth and build up, and there was a lack of regular microbiological testing of the company’s water system. The company also failed to follow written procedures for process control and production.


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