Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West
Form 483 issued December 6, 2019 · Shizuishan, China
- Inspection
- Dec 2 – Dec 6, 2019
- Investigators
- Jose M. Cayuela· Vincent Thomas
- Observations
- 2
- Pages
- 2
- FEI number
- 3012375554
In short: On December 6, 2019, FDA issued a Form 483 with 2 observations to Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West in Shizuishan, Ningxia (FEI 3012375554) after an inspection that ran Dec 2 – Dec 6, 2019. The investigators were Jose M. Cayuela and Vincent Thomas. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
ot Tle § ; , Lye FAR tree = eee…
- 02
fhe fda fotbd te APovosghly…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?
Jose M. Cayuela and Vincent Thomas are named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. 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 Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
How do I get the full Form 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.