FDA 483 - NuSil Technology LLC - July 16, 2021

Nusil Technology, LLC, an API manufacturer in Bakersfield, CA, was cited for two observations during an FDA inspection. The firm failed to maintain suitable building conditions, leading to residue on production floors and dust accumulation on retain samples. Additionally, the company did not conduct appropriate microbiological testing for objectionable microorganisms in drug components, specifically for Burkholderia cepacia contamination in water used for manufacturing.