ZS Pharma, Inc.
Form 483 issued March 29, 2016 · Coppell, Texas
- Inspection
- Mar 17 – Mar 29, 2016
- Investigators
- Massoud Motamed· Thomas J. Arista
- Observations
- 12
- Pages
- 11
- FEI number
- 3010199915
In short: On March 29, 2016, FDA issued a Form 483 with 12 observations to ZS Pharma, Inc. in Coppell, Texas (FEI 3010199915) after an inspection that ran Mar 17 – Mar 29, 2016. The investigators were Massoud Motamed and Thomas J. Arista. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 8 of 11 observations.
Most cited: 21 CFR 211.68 (3×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings, facilities and equipment are not maintained to ensure the API's identity…
- 02
Not all of the manufacturing operations’ data that is captured by the computer…
- 03
There are number of concerns with respect to the\ (b) (4) [LR£> System e.g., no rationale…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Massoud Motamed
20 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Texas.
The firmZS Pharma, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZS Pharma, Inc.?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected ZS Pharma, Inc.?
Massoud Motamed and Thomas J. Arista are named on this Form 483, for the inspection of Mar 17 – Mar 29, 2016. Each investigator has a profile showing what they cite most.
When was ZS Pharma, Inc. inspected by FDA?
The inspection ran Mar 17 – Mar 29, 2016, and the Form 483 is dated March 29, 2016.
How do I get the full Form 483 for ZS Pharma, 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.