Stephenie M. Ortiz
FDA investigator
Appears on 4 documents from 2024 to 2025, mostly at sites in New Jersey. Most often cites control of microbiological contamination (21 CFR 211.113).
- 4
- Documents on file
- 2.5
- Observations per 483
- 2024
- First seen
- 2025
- Most recent
What they cite most
From 7 observations- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.180(e)(1)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.42(c)(10)(vi)Design and construction features1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
Activity by year
2024: 1, 2025: 3
Where
New Jersey 2 · Kentucky 1 · Pennsylvania 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-08-11 | 483 Molecular PharmaGroup LLCAug 11, 2025 · New Providence, New Jersey | New Providence, New Jersey | 3 | |
| 2025-04-22 | 483 Catalent Pharma Solutions, LLCApr 22, 2025 · Winchester, Kentucky | Winchester, Kentucky | 4 | |
| 2025-03-27 | 483 PhytogenX, Inc.Mar 27, 2025 · Morgantown, Pennsylvania | Morgantown, Pennsylvania | 2 | |
| 2024-10-22 | 483 Fairy Tales Hair Care IncOct 22, 2024 · Fairfield, New Jersey | Fairfield, New Jersey | 1 |
About this profile
What does Stephenie M. Ortiz inspect?
Stephenie M. Ortiz appears on 4 documents on file covering 4 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.165(b) and 21 CFR 211.180(e)(1).
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Stephenie M. Ortiz is dated Aug 11, 2025.