Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou

Form 483 issued November 17, 2023 · igsu, China

Inspection: Nov 13 – Nov 17, 2023
Investigators: Crystal Monroy· Khoa Nathan V. Tran
Observations: 1
Pages: 4

In short: On November 17, 2023, FDA issued a Form 483 with 1 observation to Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou in igsu, China after an inspection that ran Nov 13 – Nov 17, 2023. The investigators were Crystal Monroy and Khoa Nathan V. Tran. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.100 (1×) · 211.188 (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 211.100 21 CFR 211.188
Your firm failed to establish adequate written procedures for production and process controls designed to assure…

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This inspection in context

The investigator

Crystal Monroy

15 documents · 2014–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.

The firm

Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.100

See how FDA wrote the same problem up elsewhere.

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Complete the picture

Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou 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 Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou?

FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.

Who inspected Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou?

Crystal Monroy and Khoa Nathan V. Tran are named on this Form 483, for the inspection of Nov 13 – Nov 17, 2023. Each investigator has a profile showing what they cite most.

When was Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou inspected by FDA?

The inspection ran Nov 13 – Nov 17, 2023, and the Form 483 is dated November 17, 2023.

How do I get the full Form 483 for Jiangsu Intco Medical Products Co., Ltd. 298 Yandunshan Road, Dagangzhen Jingkou?

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.