Sumitomo Makes GMP Changes After Warning Letter

Sumitomo Chemical is making several manufacturing changes after its system design raised serious concerns about microbial and endotoxin levels, according to an FDA warning letter, dated Aug. 24 and posted recently to the FDA’s website.

One of the active pharmaceutical ingredient (API) maker’s systems — redacted in the letter — is not designed to minimize the risk of microbial contamination, according to the letter. The FDA also notes one of the company’s tanks cannot be drained and has been in use since 1990, and the design of one of its distribution pipes is not conducive to controlling the system’s microbial and endotoxin levels.

Sumitomo’s response to Form 483 observations states that it is replacing the distribution pipes, connections and flexible hoses. The company also plans to replace the tank with a new drainable one, Kazuyoshi Nagaoka, general manager of Sumitomo’s fine chemicals quality assurance office, said.
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