GSK’s South Carolina Plant Hit With Form 483

September 30, 2015

GlaxoSmithKline’s Aiken, S.C., plant received a four-observation Form 483 from the FDA for failing to follow quality control procedures and other GMP violations.

During the July 6 to 10 inspection, investigators noted that the quality control unit failed to investigate a dissolution problem with Panadol extra-strength tablets within the required timeframe and didn’t provide a written justification for the delay. The unit also failed to investigate the incorrect labeling of another Panadol batch.

The QC unit also took too long to complete an out-of-specification assay result for Nicorette lozenges and didn’t prepare an interim report, the Form 483 says.

The investigator also dinged GSK’s complaint handling procedures. In one case, the company determined that a brown substance in a bottle of Beano tablets was not the result of manufacturing, but didn’t evaluate whether it could have occurred during packaging.

An investigation of another complaint regarding different size capsules in a bottle of Alli 60 mg concluded that tampering happened after the product left the facility, leading to a March 2014 recall. However, there was no follow-up to ensure that all recalled products were removed from the market, the 483 says.

FDA investigators also found a rejected batch of Panadol extra-strength tablets stored in the facility’s warehouse near the incoming receiving area, rather than the rejection cage or a trailer as per the site’s standard operating procedure—but the deviation was never investigated, the 483 says.

Finally, the drugmaker failed to clean and perform timely checks of bug zappers used to kill insects that get inside the manufacturing plant.

GSK’s Clifton, N.J., OTC facility received a 483 in 2012 for similar mishaps, including failure to review out-of-specification results, justify a deviation from change controls and properly handle complaints. The facility closed the following year due to budgetary concerns, and the oral care business was moved to Oak Hill, N.Y.

GSK did not comment by press time. The From 483 is available at www.fdanews.com/09-25-15-GSK483.pdf. — Kellen Owings