Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West

Form 483 issued October 15, 2018 · Shizuishan, China

Inspection: Oct 15, 2018
Investigator: Joel D. Hustedt
Observations: 12
Pages: 9
FEI number: 3012375554

In short: On October 15, 2018, FDA issued a Form 483 with 12 observations to Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West in Shizuishan, Ningxia (FEI 3012375554) after an inspection that ran Oct 15, 2018. The investigator was Joel D. Hustedt. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

Observations span 4 systems, led by laboratory controls.

Laboratory controls3

Facilities & equipment2

Materials2

Quality system2

Other3

Most cited: 21 CFR 211.160 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.67
Production equipment is not…
02
21 CFR 211.80 21 CFR 211.142
Warehousing controls and procedures…
03
21 CFR 211.58 21 CFR 211.56
Facilities arc not maintained in an…
04
21 CFR 211.125 21 CFR 211.130
Labeling procedures and controls are inadequate: a) In warehouse 303, numerous pallets ofww andww were stored…

8 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

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 firm

Livzon 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 483s

Other sites cited under 211.160

See how FDA wrote the same problem up elsewhere.

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Complete the picture

Amended 483
Amended 483 from this inspectionOct 19, 2018$99

Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West site file

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Questions about this 483

What did FDA find at Livzon Group (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?

FDA listed 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. 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 (Ningxia) Pharmaceutical Co., Ltd. Toushi Road West?

Joel D. Hustedt is named on this Form 483, for the inspection of Oct 15, 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, 2018, and the Form 483 is dated October 15, 2018.

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.