ZiphyCare, Inc
Form 483 issued September 6, 2022 · New York, New York
- Inspection
- Aug 30 – Sep 6, 2022
- Investigator
- Colin E. Tack
- Observations
- 4
- Pages
- 5
- FEI number
- 3011682748
In short: On September 6, 2022, FDA issued a Form 483 with 4 observations to ZiphyCare, Inc in New York, New York (FEI 3011682748) after an inspection that ran Aug 30 – Sep 6, 2022. The investigator was Colin E. Tack. Most observations concern production & process controls and design controls.
At a glance
Observations span 3 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Procedmes for design change…
- 03
Document control procedures have…
- 04
Promised to…
This inspection in context
Colin E. Tack
8 documents · 2019–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmZiphyCare, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZiphyCare, Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls, design controls and records & documents. The opening words of each observation are shown on this page.
Who inspected ZiphyCare, Inc?
Colin E. Tack is named on this Form 483, for the inspection of Aug 30 – Sep 6, 2022. Each investigator has a profile showing what they cite most.
When was ZiphyCare, Inc inspected by FDA?
The inspection ran Aug 30 – Sep 6, 2022, and the Form 483 is dated September 6, 2022.
How do I get the full Form 483 for ZiphyCare, 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.