Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs? A California firm has just found out, courtesy of the FDA.
Newport Beach, California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week.
During an inspection in March, FDA investigators found that Calvin Scott used suspect heat-sealed pouches to package its version of hydrochlorothiazide, a common diuretic used to treat high blood pressure.
The packaging included one transparent side that was susceptible to light exposure, making the listed expiration date unsupportable, the FDA said. Calvin Scott pledged to change its packaging after the inspection, but the FDA said the company didn't do enough to address other potential flaws during its review.
Investigators also found Calvin Scott had inadequate cleaning procedures in place, which led to its drug products sharing multiple surfaces and potentially being cross-contaminated.
The company shut down its repackaging system after acknowledging it didn't have adequate cleaning protocols, but the FDA found Calvin Scott's mea culpa didn't paint a full portrait of how the company would address those issues in the future.
Finally, the agency accused Calvin Scott of failing to retain an independent quality control manager to spot issues in its operations. The company hired an outside consultant as it looks for a permanent technician, but the FDA told the company it hadn't assured the agency the quality control manager would hold independent oversight powers.
In a voicemail this week, Robert Palm, Calvin Scott's VP of marketing, said the firm was working to "get its ducks in a row" and planned to respond to the FDA within the 15-day window.
This isn't the FDA's first run-in with a drug repackager that didn't meet its standards.
In December, the FDA blasted Massachusetts-based Lohxa in a warning letter for giving lots of repackaged unit dose drugs, including pneumonia treatment atovaquone oral suspension, expiration dates of 12 months from repackaging but had no data to support the dates.
The company claimed to have data to support a six-month expiration date, but the FDA said it never made the information available.