Natuzen Co., Ltd.
Form 483 issued November 21, 2024 · Incheon, South Korea
- Inspection
- Nov 18 – Nov 21, 2024
- Investigators
- Gavin T. Cua· Pamela N. Agaba
- Observations
- 4
- Pages
- 3
- FEI number
- 3006731547
In short: On November 21, 2024, FDA issued a Form 483 with 4 observations to Natuzen Co., Ltd. in Incheon, South Korea (FEI 3006731547) after an inspection that ran Nov 18 – Nov 21, 2024. The investigators were Gavin T. Cua and Pamela N. Agaba. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Employees are not given training in…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmNatuzen Co., Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natuzen Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Natuzen Co., Ltd.?
Gavin T. Cua and Pamela N. Agaba are named on this Form 483, for the inspection of Nov 18 – Nov 21, 2024. Each investigator has a profile showing what they cite most.
When was Natuzen Co., Ltd. inspected by FDA?
The inspection ran Nov 18 – Nov 21, 2024, and the Form 483 is dated November 21, 2024.
How do I get the full Form 483 for Natuzen 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.