# FDA 483 - NuSil Technology LLC - July 16, 2021

Source: https://www.keypedia.com/records/483/nusil-technology-llc/53e96b17-4ecc-443c-a515-cb390022a942

> FDA 483 for NuSil Technology LLC on July 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NuSil Technology LLC
- Inspection Date: 2021-07-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2011-05-04](https://www.keypedia.com/records/warning_letter/nusil-technology-llc/a8182dee-100e-4654-96b0-a50dc1e083af)

## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/nusil-technology-llc/ef176ca7-d941-4939-89a4-be78633f5cb4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b