PhytogenX, Inc.
FDA inspection history in Morgantown, Pennsylvania, 2019 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20Two Form 483s, at Morgantown, Pennsylvania.
- 2020The longest 483 on file: 3 observations over 4 pages at Morgantown, Pennsylvania.
- 2025One Form 483, at Morgantown, Pennsylvania.
Cited most
Across all PhytogenX observations on file
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete PhytogenX file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Morgantown, Pennsylvania
Three Form 483s · 2019 to 2025 · 6 observations
Latest: Form 483, Mar 27, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-27 | 483 Form 483 | Morgantown, Pennsylvania | 2 | $99 |
| 2020-02-10 | 483 Form 483 | Morgantown, Pennsylvania | 3 | $99 |
| 2019-02-14 | 483 Form 483 | Morgantown, Pennsylvania | 1 | $99 |
Investigators on these documents
Christina K. Theodorou (1)Rachael O. Oyewole (1)Stephenie M. Ortiz (1)Suzanne M. Healy (1)
FEI number 3006892202 · most recent document Mar 27, 2025
About PhytogenX, Inc.
How many FDA Form 483s has PhytogenX, Inc. received?
FDA Intel has 3 Form 483s on file for PhytogenX, Inc.; the most recent is dated Mar 27, 2025.
When was PhytogenX, Inc. last inspected by FDA?
The most recent FDA inspection document on file for PhytogenX, Inc. is a Form 483 dated Mar 27, 2025, for the site in Morgantown, Pennsylvania.
What did FDA cite at PhytogenX, Inc.?
The regulations cited most in the observations on file for PhytogenX, Inc. are 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.165(b) (Testing and release for distribution), 1 time; 21 CFR 211.192 (Production record review), 1 time.