Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West
Amended 483 issued October 19, 2018 · Shizuishan, China
- Inspection
- Oct 15 – Oct 19, 2018
- Investigator
- Joel D. Hustedt
- Observations
- 1
- Pages
- 9
- FEI number
- 3012375554
In short: On October 19, 2018, FDA issued a Amended 483 with 1 observation to Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West in Shizuishan, China (FEI 3012375554) after an inspection that ran Oct 15 – Oct 19, 2018. The investigator was Joel D. Hustedt. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this amended 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production equipment is not…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmLivzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?
Joel D. Hustedt is named on this Amended 483, for the inspection of Oct 15 – Oct 19, 2018. Each investigator has a profile showing what they cite most.
When was Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West inspected by FDA?
The inspection ran Oct 15 – Oct 19, 2018, and the Amended 483 is dated October 19, 2018.
How do I get the full Amended 483 for Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?
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.