I nnovati ve Intra thecal Solutions, Inc.
Form 483 issued December 18, 2017 · Murrieta, California
- Inspection
- Oct 2 – Dec 18, 2017
- Investigators
- Alan P. Kurtzberg· Liming Zhang
- Observations
- 6
- Pages
- 3
- FEI number
- 3013556857
In short: On December 18, 2017, FDA issued a Form 483 with 6 observations to I nnovati ve Intra thecal Solutions, Inc. in Murrieta, California (FEI 3013556857) after an inspection that ran Oct 2 – Dec 18, 2017. The investigators were Alan P. Kurtzberg and Liming Zhang. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 5 of 6 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113
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 6 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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.?
Alan P. Kurtzberg and Liming Zhang are named on this Form 483, for the inspection of Oct 2 – Dec 18, 2017. 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 2 – Dec 18, 2017, and the Form 483 is dated December 18, 2017.
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.