I nnovati ve Intra thecal Solutions, Inc.
Form 483 issued February 20, 2020 · Murrieta, California
- Inspection
- Feb 14 – Feb 20, 2020
- Investigator
- Rumany C. Penn
- Observations
- 10
- Pages
- 5
- FEI number
- 3013556857
In short: On February 20, 2020, FDA issued a Form 483 with 10 observations to I nnovati ve Intra thecal Solutions, Inc. in Murrieta, California (FEI 3013556857) after an inspection that ran Feb 14 – Feb 20, 2020. The investigator was Rumany C. Penn. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 9 of 10 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO S classified aseptic processing areas had difficult to clean and visibly dirty…
- 02
You had inadequate HEPA fi lter coverage and air/low over the area to which sterile…
- 03
Your firm fa iled to conduct adequate cleaning and disinfection…
- 04
Materials or supplies were not disinfected prior to entering…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) 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.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at I nnovati ve Intra thecal Solutions, Inc.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected I nnovati ve Intra thecal Solutions, Inc.?
Rumany C. Penn is named on this Form 483, for the inspection of Feb 14 – Feb 20, 2020. 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 Feb 14 – Feb 20, 2020, and the Form 483 is dated February 20, 2020.
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.