FDAnews
www.fdanews.com/articles/145598-hi-tech-handed-483-for-deficient-dust-control

Hi-Tech Handed 483 for Deficient Dust Control

April 13, 2012
A seven-observation Form 483 handed to Hi-Tech Phamacal cites deficient dust control at the contract manufacturer’s Amityville, N.Y., facility. When viewing compounding of sulfamethoxazole-trimethoprim suspension, agency investigators and plant managers were cautioned by a tank operator to stand away because of a large amount of dust being generated, according to the Oct. 19, 2011, form. Investigators subsequently learned that equipment installed to collect the dust, which had spread to adjacent compounding equipment, was not working properly.
Drug GMP Report