Hanacos CO., Ltd.
Form 483 issued December 1, 2023 · Dunnae-myeon, South Korea
- Inspection
- Nov 27 – Dec 1, 2023
- Investigator
- Sonya M. Edmonds
- Observations
- 7
- Pages
- 3
- FEI number
- 3010166993
In short: On December 1, 2023, FDA issued a Form 483 with 7 observations to Hanacos CO., Ltd. in Dunnae-myeon, Hoengseong (FEI 3010166993) after an inspection that ran Nov 27 – Dec 1, 2023. The investigator was Sonya M. Edmonds. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not include…
- 0221 CFR 210
Employees are not given taining in current good…
- 03
Records are not maintained so that data therein can be reviewed at least annually (o evaluate…
- 04
Whitten procedures are not for the cleaning and maintenance of equipment, including utensils, used in the…
This inspection in context
Sonya M. Edmonds
12 documents · 2016–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmHanacos CO., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hanacos CO., Ltd.?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Hanacos CO., Ltd.?
Sonya M. Edmonds is named on this Form 483, for the inspection of Nov 27 – Dec 1, 2023. Each investigator has a profile showing what they cite most.
When was Hanacos CO., Ltd. inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
How do I get the full Form 483 for Hanacos 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.