Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone

Form 483 issued April 24, 2026 · Lianyungang, China

Inspection: Apr 16 – Apr 24, 2026
Investigators: Karen A. Briggs· Sandra A. Boyd
Observations: 1
Pages: 16

In short: On April 24, 2026, FDA issued a Form 483 with 1 observation to Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone in Lianyungang, China after an inspection that ran Apr 16 – Apr 24, 2026. The investigators were Karen A. Briggs and Sandra A. Boyd. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.113 (1×)

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 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…

The full 483

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This inspection in context

The investigator

Karen A. Briggs

19 documents · 2021–2026

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.

The firm

Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Complete the picture

Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone site file

Every document for this site, in date order, with what was cited at each inspection.

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Questions about this 483

What did FDA find at Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone?

FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone?

Karen A. Briggs and Sandra A. Boyd are named on this Form 483, for the inspection of Apr 16 – Apr 24, 2026. Each investigator has a profile showing what they cite most.

When was Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone inspected by FDA?

The inspection ran Apr 16 – Apr 24, 2026, and the Form 483 is dated April 24, 2026.

How do I get the full Form 483 for Jiangsu Hansoh Pharmaceutical Group Co. Ltd. No 5. Dongjin Road, Economic and Technical Development Zone?

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.