Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Form 483 issued August 3, 2018 · Fuqing, China
- Inspection
- Jul 30 – Aug 3, 2018
- Investigators
- Nicole E. Knowlton· Santos E. Camara
- Observations
- 4
- Pages
- 2
- FEI number
- 3006772356
In short: On August 3, 2018, FDA issued a Form 483 with 4 observations to Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd. in Fuqing, Fujian (FEI 3006772356) after an inspection that ran Jul 30 – Aug 3, 2018. The investigators were Nicole E. Knowlton and Santos E. Camara. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to ensure™!hased in the final manufacturing steps of a non-sterile API either intended for a…
- 02
Failure to follow and document laboratory controls at…
- 03
Failure to perform equipment calibrations using standards…
- 04
Failure to demonstrate used in the manufacture of your API is suitable…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmLivzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.?
Nicole E. Knowlton and Santos E. Camara are named on this Form 483, for the inspection of Jul 30 – Aug 3, 2018. Each investigator has a profile showing what they cite most.
When was Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jul 30 – Aug 3, 2018, and the Form 483 is dated August 3, 2018.
How do I get the full Form 483 for Livzon Group Fuzhou Fuxing Pharmaceutical Co., 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.