FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Texas Drugmaker Called Out for Quality Issues

Nov. 20, 2018
A A

The FDA cited OTC drugmaker Quest Specialty of Brenham, Texas, for lacking written quality procedures during a July 31-August 3 inspection.

The facility had no written procedures explaining the roles and responsibilities of its quality control unit for approval or rejection of drug products, components, labeling and containers, the agency said.

The inspector also found multiple instances in which the facility failed to thoroughly review batches or components when they didn’t meet specifications.

View today's stories