NuSil Technology LLC
Form 483 issued July 16, 2021 · Bakersfield, California
- Inspection
- Jul 13 – Jul 16, 2021
- Investigators
- Alan L. Truong· Claudia M. Perez-Kasmarski· Scott N. Lim
- Observations
- 2
- Pages
- 3
- FEI number
- 3005140091
In short: On July 16, 2021, FDA issued a Form 483 with 2 observations to NuSil Technology LLC in Bakersfield, California (FEI 3005140091) after an inspection that ran Jul 13 – Jul 16, 2021. The investigators were Alan L. Truong, Claudia M. Perez-Kasmarski and Scott N. Lim. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.56 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 02
Each batch of drug component required to be free of objectionable microorganisms is not tested…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmNuSil Technology LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NuSil Technology LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected NuSil Technology LLC?
Alan L. Truong, Claudia M. Perez-Kasmarski and Scott N. Lim are named on this Form 483, for the inspection of Jul 13 – Jul 16, 2021. Each investigator has a profile showing what they cite most.
When was NuSil Technology LLC inspected by FDA?
The inspection ran Jul 13 – Jul 16, 2021, and the Form 483 is dated July 16, 2021.
How do I get the full Form 483 for NuSil Technology LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.