PhytogenX, Inc.
Form 483 issued March 27, 2025 · Morgantown, Pennsylvania
- Inspection
- Mar 24 – Mar 27, 2025
- Investigator
- Stephenie M. Ortiz
- Observations
- 2
- Pages
- 4
- FEI number
- 3006892202
In short: On March 27, 2025, FDA issued a Form 483 with 2 observations to PhytogenX, Inc. in Morgantown, Pennsylvania (FEI 3006892202) after an inspection that ran Mar 24 – Mar 27, 2025. The investigator was Stephenie M. Ortiz. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.84(d)(2) (1×) · 211.165(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Stephenie M. Ortiz
4 documents · 2024–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
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 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PhytogenX, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected PhytogenX, Inc.?
Stephenie M. Ortiz is named on this Form 483, for the inspection of Mar 24 – Mar 27, 2025. Each investigator has a profile showing what they cite most.
When was PhytogenX, Inc. inspected by FDA?
The inspection ran Mar 24 – Mar 27, 2025, and the Form 483 is dated March 27, 2025.
How do I get the full Form 483 for PhytogenX, Inc.?
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