McCallum, a U.K.-based drugmaker, was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.
In the letter posted on the regulatory agency’s website, the FDA took McCallum to task when the company said in response to a July 2017 inspection that it was too small an enterprise and didn’t have the resources for a quality unit.
“Regardless of the size of your company, as a drug manufacturer, you must have a quality unit that is responsible for and authorized to perform certain operations,” the FDA wrote.
McCallum, an over-the-counter manufacturing operation, was found to lack testing procedures, specifications and analytical data to support the release of its products. The company also didn’t have adequate written procedures for production and process control in place, as well as failing to prepare batch production and control records.
The agency recommended the company hire a CGMP consultant to fix the issues.