OTC Drug Manufacturer Warned On GMP Problems FDA Initially Found In 2010

"In response to each of those inspections and compliance actions taken against your firm, you proposed specific remediations to fully address the violations," says FDA in warning letter to TG United. Firm in 2013 recalled 44 products – totaling some 688,000 containers plus 2.53m pills or tablets distributed in bulk – due to GMP deviations.

After four inspections in seven years finding manufacturing quality-control problems, a "Regulatory Meeting" in 2012 and recalls in 2013 of nearly 700,000 packages and more than 2.5m individual drugs shipped in bulk, US OTC firm TG United Inc. has received a warning letter.

"In response to each of those inspections and compliance actions taken against your firm, you proposed specific remediations to fully...