Innoveix Pharmaceuticals Inc.
FDA inspection history in Addison, Texas, 2019 to 2022
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Two Form 483s and one warning letter, at Addison, Texas.
- 2021The longest 483 on file: 9 observations over 6 pages at Addison, Texas.
Cited most
Across all Innoveix Pharmaceuticals observations on file
- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.167Special testing requirements1
- 21 CFR 211.63Equipment design, size, and location1
The complete Innoveix Pharmaceuticals 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
Addison, Texas
Two Form 483s and one warning letter · 2019 to 2022 · 18 observations
Latest: Warning letter, Jan 26, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-26 | Warning letter Warning letter | Addison, Texas | — | $99 |
| 2021-05-27 | 483 Form 483 | Addison, Texas | 9 | $99 |
| 2019-09-12 | 483 Form 483 | Addison, Texas | 9 | $99 |
Investigators on these documents
FEI number 3012907473 · most recent document Jan 26, 2022
About Innoveix Pharmaceuticals Inc.
How many FDA Form 483s has Innoveix Pharmaceuticals Inc. received?
FDA Intel has 2 Form 483s on file for Innoveix Pharmaceuticals Inc.; the most recent is dated May 27, 2021.
When was Innoveix Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Innoveix Pharmaceuticals Inc. is a Form 483 dated May 27, 2021, for the site in Addison, Texas.
What did FDA cite at Innoveix Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Innoveix Pharmaceuticals Inc. are 21 CFR 211.113 (Control of microbiological contamination), 9 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.42 (Design and construction features), 2 times.
Has Innoveix Pharmaceuticals Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Innoveix Pharmaceuticals Inc.; the most recent is dated Jan 26, 2022.