PhytogenX, Inc.
Form 483 issued February 14, 2019 · Morgantown, Pennsylvania
- Inspection
- Feb 7 – Feb 14, 2019
- Investigator
- Suzanne M. Healy
- Observations
- 1
- Pages
- 3
- FEI number
- 3006892202
In short: On February 14, 2019, FDA issued a Form 483 with 1 observation to PhytogenX, Inc. in Morgantown, Pennsylvania (FEI 3006892202) after an inspection that ran Feb 7 – Feb 14, 2019. The investigator was Suzanne M. Healy. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no documentation of the revalidation of a process performed in response to…
This inspection in context
Suzanne M. Healy
5 documents · 2017–2023
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPhytogenX, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PhytogenX, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected PhytogenX, Inc.?
Suzanne M. Healy is named on this Form 483, for the inspection of Feb 7 – Feb 14, 2019. Each investigator has a profile showing what they cite most.
When was PhytogenX, Inc. inspected by FDA?
The inspection ran Feb 7 – Feb 14, 2019, and the Form 483 is dated February 14, 2019.
How do I get the full Form 483 for PhytogenX, 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.