Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-01-15.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 15 Jan 2026 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jan 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Christina K Theodorou, Ofuje D Daniyan
15 Jan 2026
21 CFR 211.166(a)
Lack of written stability program
Cited by Christina K Theodorou, Ofuje D Daniyan
15 Jan 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Christina K Theodorou, Ofuje D Daniyan
15 Jan 2026
21 CFR 211.42(b)
Adequate space lacking to prevent mix-ups and contamination
Cited by Christina K Theodorou, Ofuje D Daniyan
15 Jan 2026
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Christina K Theodorou, Ofuje D Daniyan
Investigators
FDA investigators tied to this site in the record.
Christina K Theodorou1 insp.
Ofuje D Daniyan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind FairyGene, Inc.'s 1 Form 483
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat