GenoGenix
FDA inspection history in Boca Raton, Florida, 2025 to 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2025–26One Form 483 and one warning letter, at Boca Raton, Florida.
Cited most
Across all GenoGenix observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.115Reprocessing1
- 21 CFR 211.125Labeling issuance1
The complete GenoGenix file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boca Raton, Florida
One warning letter and one Form 483 · 2025 to 2026 · 16 observations
Latest: Warning letter, Jan 20, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-20 | Warning letter Warning letter | Boca Raton, Florida | — | $99 |
| 2025-07-18 | 483 Form 483 | Boca Raton, Florida | 16 | $99 |
Investigators on these documents
FEI number 3032144832 · most recent document Jan 20, 2026
About GenoGenix
How many FDA Form 483s has GenoGenix received?
FDA Intel has 1 Form 483 on file for GenoGenix; the most recent is dated Jul 18, 2025.
When was GenoGenix last inspected by FDA?
The most recent FDA inspection document on file for GenoGenix is a Form 483 dated Jul 18, 2025, for the site in Boca Raton, Florida.
What did FDA cite at GenoGenix?
The regulations cited most in the observations on file for GenoGenix are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.
Has GenoGenix received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for GenoGenix; the most recent is dated Jan 20, 2026.