I.V. Specialty Ltd.
FDA inspection history in Austin, Texas, 2015 to 2020
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one warning letter; 2016: one Form 483; 2017: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s and one warning letter, at Austin, Texas.
- 2020One Form 483, at Austin, Texas.
- 2020The longest 483 on file: 10 observations over 5 pages at Austin, Texas.
Cited most
Across all I.V. Specialty observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.28Personnel responsibilities2
The complete I.V. Specialty file.
All 4 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
Austin, Texas
Three Form 483s and one warning letter · 2015 to 2020 · 24 observations
Latest: Form 483, Jul 22, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-07-22 | 483 Form 483 | Austin, Texas | 10 | $99 |
| 2017-07-28 | 483 Form 483 | Austin, Texas | 6 | $99 |
| 2016-02-05 | 483 Form 483 | Austin, Texas | 8 | $99 |
| 2015-04-21 | Warning letter Warning letter | Austin, Texas | — | $99 |
Investigators on these documents
Lori G. Cantin (1)Massoud Motamed (1)Nimmy Mathews (1)Scott Ballard (1)Shelby N. Marler (1)
FEI number 3010836489 · most recent document Jul 22, 2020
About I.V. Specialty Ltd.
How many FDA Form 483s has I.V. Specialty Ltd. received?
FDA Intel has 3 Form 483s on file for I.V. Specialty Ltd.; the most recent is dated Jul 22, 2020.
When was I.V. Specialty Ltd. last inspected by FDA?
The most recent FDA inspection document on file for I.V. Specialty Ltd. is a Form 483 dated Jul 22, 2020, for the site in Austin, Texas.
What did FDA cite at I.V. Specialty Ltd.?
The regulations cited most in the observations on file for I.V. Specialty Ltd. are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.167 (Special testing requirements), 2 times.
Has I.V. Specialty Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for I.V. Specialty Ltd.; the most recent is dated Apr 21, 2015.