Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And

Form 483 issued March 21, 2025 · Nanjing, China

Inspection: Mar 17 – Mar 21, 2025
Investigator: Nicholas L. Hunt
Observations: 3
Pages: 3
FEI number: 3027129265

In short: On March 21, 2025, FDA issued a Form 483 with 3 observations to Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And in Nanjing, Jiangsu (FEI 3027129265) after an inspection that ran Mar 17 – Mar 21, 2025. The investigator was Nicholas L. Hunt. Most observations concern facilities & equipment and laboratory controls.

At a glance

2 of 3 observations on this 483 concern facilities & equipment.

Facilities & equipment2

Laboratory controls1

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
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
02
21 CFR 211.68
Routine checking of automatic and electronic equipment is not performed according to a written program designed…
03
21 CFR 211.166
The written stability testing…

The full 483

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This inspection in context

The investigator

Nicholas L. Hunt

38 documents · 2017–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.

The firm

Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.67

See how FDA wrote the same problem up elsewhere.

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Complete the picture

Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And 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 Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And?

FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.

Who inspected Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And?

Nicholas L. Hunt is named on this Form 483, for the inspection of Mar 17 – Mar 21, 2025. Each investigator has a profile showing what they cite most.

When was Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And inspected by FDA?

The inspection ran Mar 17 – Mar 21, 2025, and the Form 483 is dated March 21, 2025.

How do I get the full Form 483 for Nanjing Cuccess Pharmaceutical Co., Ltd. Nanjing Economic, 20 Xingang Avenue; And?

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.