ZS Pharma, Inc.
FDA inspection history in Coppell, Texas, 2016 to 2017
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s, at Coppell, Texas.
- 2016The longest 483 on file: 12 observations over 11 pages at Coppell, Texas.
Cited most
Across all ZS Pharma observations on file
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.160General requirements3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
The complete ZS Pharma file.
All 2 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
Coppell, Texas
Two Form 483s · 2016 to 2017 · 18 observations
Latest: Form 483, Jan 30, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-01-30 | 483 Form 483 | Coppell, Texas | 6 | $99 |
| 2016-03-29 | 483 Form 483 | Coppell, Texas | 12 | $99 |
Investigators on these documents
FEI number 3010199915 · most recent document Jan 30, 2017
About ZS Pharma, Inc.
How many FDA Form 483s has ZS Pharma, Inc. received?
FDA Intel has 2 Form 483s on file for ZS Pharma, Inc.; the most recent is dated Jan 30, 2017.
When was ZS Pharma, Inc. last inspected by FDA?
The most recent FDA inspection document on file for ZS Pharma, Inc. is a Form 483 dated Jan 30, 2017, for the site in Coppell, Texas.
What did FDA cite at ZS Pharma, Inc.?
The regulations cited most in the observations on file for ZS Pharma, Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.160 (General requirements), 3 times.