The FDA has handed Jubilant HollisterStier a warning letter for quality shortcomings at its Spokane, Wash., sterile drug manufacturing facility.

The predominant concern cited in the warning letter involves deviations from the company’s standard operating procedure for quality unit oversight and aseptic processing following a “significant maintenance” shutdown. The procedure lacks provisions for adequate impact evaluation of a shutdown on product quality, the agency says in the letter published Tuesday.

The FDA also chides Jubilant for failing to address the proper use of sporicidal agents in revisions to its procedure on cleaning, sanitization and disinfection of aseptic controlled areas. Improper use of those agents may have led to impurities in lots of finished product, the letter states. In response, the agency urges the company to implement corrective actions to ensure adequate control throughout the product lifecycle.

“The items listed lead us to question the effectiveness of your current quality system to achieve overall compliance with [current good manufacturing practices] at your facility,” the FDA said.

A spokesman for the company Tuesday declined to detail Jubilant’s plans for addressing the observations noted in the letter.

Read the warning letter at www.fdanews.com/ext/resources/files/12/12-10-13-JubilantWL.pdf. — Lena Freund