Hanmi Pharm. Co., Ltd.

Form 483 issued February 1, 2018 · Pyeongtaek, South Korea

Inspection: Jan 29 – Feb 1, 2018
Investigator: Joseph R. Strelnik
Observations: 1
Pages: 3
FEI number: 3009350213

In short: On February 1, 2018, FDA issued a Form 483 with 1 observation to Hanmi Pharm. Co., Ltd. in Pyeongtaek, Gyeonggi-do (FEI 3009350213) after an inspection that ran Jan 29 – Feb 1, 2018. The investigator was Joseph R. Strelnik. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.40 (document controls).

At a glance

1 of 1 observations on this 483 concern records & documents.

Records & documents1

Most cited: 21 CFR 820.40 (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 820.40
Document control procedures have…

The full 483

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This inspection in context

The investigator

Joseph R. Strelnik

13 documents · 2011–2022

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.

The firm

Hanmi Pharm. Co., Ltd. history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.40

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Hanmi Pharm. Co., Ltd.?

FDA listed 1 observation on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.40 (document controls). The opening words of each observation are shown on this page.

Who inspected Hanmi Pharm. Co., Ltd.?

Joseph R. Strelnik is named on this Form 483, for the inspection of Jan 29 – Feb 1, 2018. Each investigator has a profile showing what they cite most.

When was Hanmi Pharm. Co., Ltd. inspected by FDA?

The inspection ran Jan 29 – Feb 1, 2018, and the Form 483 is dated February 1, 2018.

How do I get the full Form 483 for Hanmi Pharm. Co., Ltd.?

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.