Fujian Genohope Biotech Ltd.
Form 483 issued June 2, 2023 · Putian, China
- Inspection
- May 25 – Jun 2, 2023
- Investigators
- Kevin T. Nguyen· Nicole E. Knowlton
- Observations
- 6
- Pages
- 7
- FEI number
- 3025263427
In short: On June 2, 2023, FDA issued a Form 483 with 6 observations to Fujian Genohope Biotech Ltd. in Putian, Fujian (FEI 3025263427) after an inspection that ran May 25 – Jun 2, 2023. The investigators were Kevin T. Nguyen and Nicole E. Knowlton. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 4 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the receipt, identification, storage, handling, sampling, testing, approval and rejection…
- 02
Equipment used in the manufacture, processing, packing or holding of dmg products is not of appropriate…
- 03
Input to and output from the computer and records or data are…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Kevin T. Nguyen
5 documents · 2022–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Texas.
The firmFujian Genohope Biotech Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fujian Genohope Biotech Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Fujian Genohope Biotech Ltd.?
Kevin T. Nguyen and Nicole E. Knowlton are named on this Form 483, for the inspection of May 25 – Jun 2, 2023. Each investigator has a profile showing what they cite most.
When was Fujian Genohope Biotech Ltd. inspected by FDA?
The inspection ran May 25 – Jun 2, 2023, and the Form 483 is dated June 2, 2023.
How do I get the full Form 483 for Fujian Genohope Biotech Ltd.?
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.