An FDA warning letter is an ignominious sign for any company and a wake-up call for change. But two warning letters in one year? That's an alarm bell for most companies—a fact that a Pennsylvania-based drugmaker is finding out the hard way after a new FDA notice.
FDA investigators accused KVK-Tech of failing to set up the proper policies to surfaces used in packaging operations at its Newtown, Pennsylvania plant despite the agency's prior wrist slap in April, according to a warning letter posted online this week.
During an inspection between February and March, investigators found the company did not have proper cleaning protocols for a slat table used in packaging its oral solid-dose drugs, which were redacted in the letter.
The company believed the surface was the same one used at a second Newtown facility, but the FDA said that was inaccurate and could have led to an accumulation of contaminants that could harm drug quality. Moreover, the company's amended cleaning protocols weren't adequate, the FDA said.
"You did not establish the worst-case scenario for cross-contamination in your new cleaning validation studies because you lacked swab sites within the slat cavities, which can be one of the most difficult-to-clean locations and a potential site of carryover," investigators wrote.
Investigators also found that air-pressure readings during the capping process for doses of hydroxyzine HCL, a generic antihistamine, were outside the normal range and that an employee had failed to record pressure readings for batches of promethazine HCL, another antihistamine used to treat nausea.
KVK linked the faulty readings back to caps misfeeding into the packaging equipment, but the FDA said the company didn't go far enough to investigate whether past batches showed the same problem.