Contractor Rapped by FDA for Absence of Quality Unit

March 6, 2015

Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations.

During a September inspection of the manufacturer’s San Diego facility, investigators discovered that Gopers has released batches since 2012 without quality control oversight.

The staples of a quality control system — production records, stability and quality testing and product specifications — are not there at all, according to the 16-observation form.

Gopers also has not tested active pharmaceutical ingredients to ensure they met specifications since October 2011, the FDA said.

The agency also found that the owner acts as the quality manager by approving and releasing batches but doesn’t have any prior experience or training in quality control. In addition, there is no documentation for all production employees, the form said.

Gopers did not return a request for comment as of press time.

Stay up to date with breaking quality stories like this one by subscribing to Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.