Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-20.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 20 Mar 2026 | Human Drugs | 483 | View 483 → |
| 21 Apr 2025 – 28 Apr 2025 | Human Drugs | 483 | View 483 → |
| 22 Feb 2022 – 1 Mar 2022 | Human Drugs | Clean | |
| 13 Jan 2020 – 17 Jan 2020 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Margaret M Annes, Oluwasefunm Agbanigo, Milton J De Jesus Tavarez
20 Mar 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Margaret M Annes, Oluwasefunm Agbanigo, Milton J De Jesus Tavarez
20 Mar 2026
21 CFR 211.182
Specific information required in individual logs
Cited by Margaret M Annes, Oluwasefunm Agbanigo, Milton J De Jesus Tavarez
20 Mar 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Margaret M Annes, Oluwasefunm Agbanigo, Milton J De Jesus Tavarez
20 Mar 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Margaret M Annes, Oluwasefunm Agbanigo, Milton J De Jesus Tavarez
Investigators
FDA investigators tied to this site in the record.
Kevin T Nguyen2 insp.
Shelby N Turner2 insp.
Margaret M Annes1 insp.
Oluwasefunm Agbanigo1 insp.
Milton J De Jesus Tavarez1 insp.
Patty P Kaewussdangkul1 insp.
Shanna N Purdy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eosera, Inc.'s 3 Form 483s
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