CDMO Sovereign takes it on the chin in FDA warning letter

The FDA has found issues with a plant operated by contract manufacturer Sovereign Pharmaceuticals, saying the plant is not only having problems with its GMP manufacturing but also is producing over-the-counter meds that don't qualify for that category.

The agency today posted a warning letter to the company for inspections that occurred more than a year ago in January and February of 2012 at its Fort Worth, TX plant. In it, the agency said Sovereign did not fully investigate the failure of a batch of its Symax SR. The agency said the company's explanation that the failure was because of blend mixing couldn't be assured because it is not conducting in-process testing.

The warning letter also found fault with Sovereign's investigation of just one lot of out-of-spec Liquibid PD-R tablets, which Sovereign blamed on a malfunctioning mixer. The warning said the company had not investigated whether the same problem had affected other lots of the product. This, the FDA said, was a repeat violation from a 2004 inspection.

The agency also took Sovereign to task for its production of a variety of OTC products it said did not meet labeling requirements. Those included Certuss, Certuss-0, Trexbrom, Tekral, Rescon GG, Rescon, Rescon OM, and Liquibid D-R. "Since we are not aware of any other evidence establishing such products are generally recognized as safe and effective, these products are new drugs," the letter said.

This is not the first time that Sovereign has received an FDA warning letter. Similar issues were raised in a warning in 1998. 

- read the warning letter
- see the warning letter from 1998 (pdf)