I nnovati ve Intra thecal Solutions, Inc.
Form 483 issued October 26, 2021 · Murrieta, California
- Inspection
- Oct 19 – Oct 26, 2021
- Investigators
- Scott N. Lim· Truong X. Nguyen
- Observations
- 1
- Pages
- 2
- FEI number
- 3013556857
In short: On October 26, 2021, FDA issued a Form 483 with 1 observation to I nnovati ve Intra thecal Solutions, Inc. in Murrieta, California (FEI 3013556857) after an inspection that ran Oct 19 – Oct 26, 2021. The investigators were Scott N. Lim and Truong X. Nguyen.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate containment, segregation and cleaning of personnel…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmI nnovati ve Intra thecal Solutions, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at I nnovati ve Intra thecal Solutions, Inc.?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected I nnovati ve Intra thecal Solutions, Inc.?
Scott N. Lim and Truong X. Nguyen are named on this Form 483, for the inspection of Oct 19 – Oct 26, 2021. Each investigator has a profile showing what they cite most.
When was I nnovati ve Intra thecal Solutions, Inc. inspected by FDA?
The inspection ran Oct 19 – Oct 26, 2021, and the Form 483 is dated October 26, 2021.
How do I get the full Form 483 for I nnovati ve Intra thecal Solutions, Inc.?
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.