Huons Co., Ltd.
Form 483 issued October 18, 2019 · Jecheon-si, South Korea
- Inspection
- Oct 7 – Oct 18, 2019
- Investigators
- Jennifer M. Gogley· Seneca Toms
- Observations
- 5
- Pages
- 5
- FEI number
- 3007163376
In short: On October 18, 2019, FDA issued a Form 483 with 5 observations to Huons Co., Ltd. in Jecheon-si, Chungcheongbuk-do (FEI 3007163376) after an inspection that ran Oct 7 – Oct 18, 2019. The investigators were Jennifer M. Gogley and Seneca Toms. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 4 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Established test procedures and laboratory control mechanisms are not documented at the time of performance…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jennifer M. Gogley
8 documents · 2007–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmHuons Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Huons Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Huons Co., Ltd.?
Jennifer M. Gogley and Seneca Toms are named on this Form 483, for the inspection of Oct 7 – Oct 18, 2019. Each investigator has a profile showing what they cite most.
When was Huons Co., Ltd. inspected by FDA?
The inspection ran Oct 7 – Oct 18, 2019, and the Form 483 is dated October 18, 2019.
How do I get the full Form 483 for Huons 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.