I nnovati ve Intra thecal Solutions, Inc.
FDA inspection history in Murrieta, California, 2017 to 2021
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2020: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Murrieta, California.
- 2020–21Two Form 483s, at Murrieta, California.
- 2020The longest 483 on file: 10 observations over 5 pages at Murrieta, California.
Cited most
Across all I nnovati ve Intra thecal Solutions observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.166Stability testing1
The complete I nnovati ve Intra thecal Solutions file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Murrieta, California
Three Form 483s · 2017 to 2021 · 17 observations
Latest: Form 483, Oct 26, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-10-26 | 483 Form 483 | Murrieta, California | 1 | $99 |
| 2020-02-20 | 483 Form 483 | Murrieta, California | 10 | $99 |
| 2017-12-18 | 483 Form 483 | Murrieta, California | 6 | $99 |
Investigators on these documents
Alan P. Kurtzberg (1)Liming Zhang (1)Rumany C. Penn (1)Scott N. Lim (1)Truong X. Nguyen (1)
FEI number 3013556857 · most recent document Oct 26, 2021
About I nnovati ve Intra thecal Solutions, Inc.
How many FDA Form 483s has I nnovati ve Intra thecal Solutions, Inc. received?
FDA Intel has 3 Form 483s on file for I nnovati ve Intra thecal Solutions, Inc.; the most recent is dated Oct 26, 2021.
When was I nnovati ve Intra thecal Solutions, Inc. last inspected by FDA?
The most recent FDA inspection document on file for I nnovati ve Intra thecal Solutions, Inc. is a Form 483 dated Oct 26, 2021, for the site in Murrieta, California.
What did FDA cite at I nnovati ve Intra thecal Solutions, Inc.?
The regulations cited most in the observations on file for I nnovati ve Intra thecal Solutions, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.