Taro's Ontario Facility Cited for GMP Violations

Hawthorne, NY (Feb. 12)-Taro Pharmaceuticals received a warning letter from the US Food and Drug Administration last week regarding its Brampton, Ontario, Canada manufacturing facility. The agency noted several current good manufacturing practice (GMP) deviations in the manufacture of nonsterile cream and ointment finished drug products.

FDA inspected the Canadian facility in July 2008. Specifically, three lots of a total 24 lots of fluocinonide cream failed the abbreviated new drug application limit of 6% for the relative standard deviation of assays for tube uniformity stability at 18- and 36-month time stations. Five lots of betamethasone valerate cream failed to meet established purity specifications at the 36- and 48-month time points for purity testing. Two of the three validation lots of ciclopirox olamine cream failed relative standard deviation specification limits for tube-content uniformity at 12-, 18-, and 24-month stability time points. And 11 lots of mupirocin ointment were assigned reduced expiration dates without adequate justification.

The Warning Letter says that Taro’s Sept. 26, 2008 response letter did not address written statements made by the FDA inspector. The agency also notes that out-of-specification results were not thoroughly investigated or performed in a timely manner.

Overall, the “quality control unit failed its responsibility to reject drug products that did not meet specifications,” says the letter.

The letter alludes to the fact that Taro may not be able to continue to ship its products to the US until compliance is ensured.