Contractor Rapped by FDA for Poor Training, Absence of Quality Unit

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

During a September 2014 inspection of the manufacturer’s San Diego facility, investigators 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 showing continuing cGMP training for all production employees, the form said.

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 has released batches since 2012 without quality control oversight, the form says. Gopers also has not tested active pharmaceutical ingredients to ensure they meet specifications since October 2011.

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

The Form 483 can be read at www.fdanews.com/01-27-14-Goper483.pdf.