NuSil Technology, a California-based maker of active pharmaceutical ingredients (APIs) and industrial silicone products, has been warned for specification testing shortfalls and microbial contamination concerns related to its simethicone emulsion USP.
FDA investigators found out-of-specification (OOS) reports lacking key data for a lot of simethicone emulsion USP that had been twice-tested for microbial contamination, the March 22 warning letter posted Tuesday states. The letter comes after an April 18 through May 4, 2011, inspection of the company’s Bakersfield, Calif., plant.
The OOS report for the lot, which was subsequently released, failed to justify the invalidation of the original results and lacked root cause determination, according to the letter. NuSil “relied solely on the acceptable retest results to release the lot,” the FDA said.
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