Dexcowin Co. Ltd.
Form 483 issued February 23, 2023 · Geumcheon-gu, South Korea
- Inspection
- Feb 20 – Feb 23, 2023
- Investigator
- Alexandria L. Capuano
- Observations
- 1
- Pages
- 4
- FEI number
- 3007065358
In short: On February 23, 2023, FDA issued a Form 483 with 1 observation to Dexcowin Co. Ltd. in Geumcheon-gu, South Korea (FEI 3007065358) after an inspection that ran Feb 20 – Feb 23, 2023. The investigator was Alexandria L. Capuano. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Alexandria L. Capuano
6 documents · 2022–2026
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in California.
The firmDexcowin Co. Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dexcowin Co. Ltd.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Dexcowin Co. Ltd.?
Alexandria L. Capuano is named on this Form 483, for the inspection of Feb 20 – Feb 23, 2023. Each investigator has a profile showing what they cite most.
When was Dexcowin Co. Ltd. inspected by FDA?
The inspection ran Feb 20 – Feb 23, 2023, and the Form 483 is dated February 23, 2023.
How do I get the full Form 483 for Dexcowin Co. Ltd.?
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