PhytogenX, Inc.
Form 483 issued February 10, 2020 · Morgantown, Pennsylvania
- Inspection
- Jan 30 – Feb 10, 2020
- Investigators
- Christina K. Theodorou· Rachael O. Oyewole
- Observations
- 3
- Pages
- 4
- FEI number
- 3006892202
In short: On February 10, 2020, FDA issued a Form 483 with 3 observations to PhytogenX, Inc. in Morgantown, Pennsylvania (FEI 3006892202) after an inspection that ran Jan 30 – Feb 10, 2020. The investigators were Christina K. Theodorou and Rachael O. Oyewole. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Established test procedures and laboratory control mechanisms are not followed and documented at…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PhytogenX, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected PhytogenX, Inc.?
Christina K. Theodorou and Rachael O. Oyewole are named on this Form 483, for the inspection of Jan 30 – Feb 10, 2020. Each investigator has a profile showing what they cite most.
When was PhytogenX, Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 10, 2020, and the Form 483 is dated February 10, 2020.
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.