ZS Pharma, Inc.
Form 483 issued January 30, 2017 · Coppell, Texas
- Inspection
- Jan 18 – Jan 30, 2017
- Investigators
- Jamillah Selby· Massoud Motamed
- Observations
- 6
- Pages
- 11
- FEI number
- 3010199915
In short: On January 30, 2017, FDA issued a Form 483 with 6 observations to ZS Pharma, Inc. in Coppell, Texas (FEI 3010199915) after an inspection that ran Jan 18 – Jan 30, 2017. The investigators were Jamillah Selby and Massoud Motamed. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation procedures do not ensure the integrity of process validation, and the quality unit does…
- 02
Buildings, facilities and equipment are not maintained to ensure the API's identity, strength, qual ity and…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Proper controls are not exercised over computerized systems used for analytical testing to ensure drug products…
This inspection in context
Jamillah Selby
7 documents · 2013–2024
Cites 211.42(c)(10)(iv) (design and construction features) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZS Pharma, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected ZS Pharma, Inc.?
Jamillah Selby and Massoud Motamed are named on this Form 483, for the inspection of Jan 18 – Jan 30, 2017. Each investigator has a profile showing what they cite most.
When was ZS Pharma, Inc. inspected by FDA?
The inspection ran Jan 18 – Jan 30, 2017, and the Form 483 is dated January 30, 2017.
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.