FDA finds Sandoz paperwork troubling

Letter cites quality control violations

Sandoz's pill manufacturing plant in Wilson failed to follow safeguards to ensure several of its medicines were made the same way every time.

The Food and Drug Administration noted the violations during a two-week inspection in March. Since then, the plant has also failed to properly follow up on the violations, the FDA wrote in a warning letter mailed Aug. 12.

The plant, which employs about 450, makes generic medicines, including the heart drug metoprolol succinate, muscle relaxer orphenadrine citrate and clarithromycin, an antibiotic. The facility is one of a trio of drug-manufacturing plants that make Wilson a mini hub for medicine production.

"All products released and distributed to the market met all specifications," Sandoz wrote in a statement the company released Tuesday. "The FDA warning letter is primarily related to concerns with documentation, validation controls and investigations."

But paperwork violations aren't minor problems in drug manufacturing, the FDA letter pointed out. Following detailed production and quality control procedures is meant to make sure patients get the right amount of drug with every pill they swallow.

"You do not have a high level of assurance that the process is in a state of control and is capable of consistently producing a product that meets specifications," the letter states.

The Wilson plant has 15 working days from the time it received the letter to come up with a plan to correct the violations. Failure to do so could prompt the FDA to seize drugs made at the plant.

Meanwhile, Sandoz spokesman Charles Bruns said, "the plant is up and running." He declined further comment on what steps the company is taking to address the FDA concerns.

Sandoz, a division of Swiss drugmaker Novartis, is one of three remaining drug manufacturers in Wilson. The three employ a total of about 1,000 in the city of about 50,000. Located about 50 miles east of Raleigh, Wilson has been successful recruiting manufacturing jobs in part because of its proximity to Interstate 95 and the Triangle.

In the past six months, Sandoz added about 50 jobs at its Wilson plant, offering employment opportunities for production workers laid off at other pharmaceutical plants in the area.

In March, Leiner Health Products closed its Wilson plant, laying off about 170. And GlaxoSmithKline's drug manufacturing plant in nearby Zebulon has cut 160 production jobs since February.