Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-16.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2025 – 16 May 2025 | Human Drugs | 483 | On file |
| 1 Apr 2019 – 10 Apr 2019 | Human Drugs | 483 | View 483 → |
| 1 Nov 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Apr 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Susan T Hadman, Jose F Velez
10 Apr 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Susan T Hadman, Jose F Velez
10 Apr 2019
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Susan T Hadman, Jose F Velez
Investigators
FDA investigators tied to this site in the record.
Zhong Li1 insp.
Doan N Singh1 insp.
Priscilla A Amador Do Amaral1 insp.
Susan T Hadman1 insp.
Jose F Velez1 insp.
Ileana Barreto-Pettit1 insp.
Dianiris C Ayala1 insp.
Melanie M Walker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Goodwin Biotechnology, Inc.'s 2 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