PhytogenX, Inc. FDA Inspection Record
PhytogenX, Inc. is an FDA-registered facility (FEI 3006892202) located in Morgantown, PA, US. Registered operations: MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Mar 27, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (4 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 27, 2025 | Voluntary Action Indicated (VAI) | Microbiological testing (21 CFR 211.165(b)) Reports of Analysis (Components) (21 CFR 211.84(d)(2)) |
| Jun 6, 2023 | No Action Indicated (NAI) | No citations listed |
| Feb 10, 2020 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Following/documenting laboratory controls (21 CFR 211.160(a)) Investigations of discrepancies, failures (21 CFR 211.192) |
| Feb 14, 2019 | Voluntary Action Indicated (VAI) | Documentation - review in response to changes or deviations (21 CFR 820.75(c)) |
| Jul 31, 2015 | Voluntary Action Indicated (VAI) | Equipment Design, Size and Location (21 CFR 211.63) Review of representative number of batches (21 CFR 211.180(e)(1)) Quality control unit review of records (21 CFR 211.192) Control procedures to monitor and validate performance (21 CFR 211.110(a)) and 1 more |
| Sep 30, 2010 | No Action Indicated (NAI) | Written procedures not established/followed (21 CFR 211.67(b)) Absence of Written Procedures (21 CFR 211.100(a)) Procedures for non-sterile drug products (21 CFR 211.113(a)) Complete test data included in records (21 CFR 211.194(a)) |
FDA record score
9 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
4 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Mar 27, 2025 | 6 x 1 | 6 |
| Inspection classified VAI | Feb 10, 2020 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Feb 14, 2019 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jul 31, 2015 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- PhytogenX, Inc.
- Location
- Morgantown, PA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- MANUFACTURE
- Source
- both