GenoGenix
Form 483 issued July 18, 2025 · Boca Raton, Florida
- Inspection
- Jul 14 – Jul 18, 2025
- Investigators
- Bei Y. He· Sarah M. Gauna
- Observations
- 16
- Pages
- 20
- FEI number
- 3032144832
In short: On July 18, 2025, FDA issued a Form 483 with 16 observations to GenoGenix in Boca Raton, Florida (FEI 3032144832) after an inspection that ran Jul 14 – Jul 18, 2025. The investigators were Bei Y. He and Sarah M. Gauna. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmGenoGenix history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GenoGenix?
FDA listed 16 observations on this Form 483, mostly about production, quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected GenoGenix?
Bei Y. He and Sarah M. Gauna are named on this Form 483, for the inspection of Jul 14 – Jul 18, 2025. Each investigator has a profile showing what they cite most.
When was GenoGenix inspected by FDA?
The inspection ran Jul 14 – Jul 18, 2025, and the Form 483 is dated July 18, 2025.
How do I get the full Form 483 for GenoGenix?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.