FDA Inspection
Goodwin Biotechnology, Inc.Goodwin Biotechnology, Inc. – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns Goodwin Biotechnology, Inc., with an inspection on April 10, 2019, issued by the Florida District Office, covering human drugs.
View Company Profile
ID · 2a31b784-0c95-49d7-99aa-d2d2e3c623d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085874
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Goodwin Biotechnology, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2025 | Not classified | Florida District Office | |
| November 1, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Goodwin Biotechnology, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.