Dexcowin Co. Ltd.

FDA inspection history in Geumcheon-gu, South Korea, 2015 to 2023

3
Close-outs
1
Form 483

Every document, by year

  • Close-out
  • Form 483

2015: one close-out letter; 2018: one close-out letter; 2023: one close-out letter and one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2015One close-out letter.
  2. 2018One close-out letter.
  3. 2023One close-out letter and one Form 483, at Geumcheon-gu, South Korea.

Cited most

Across all Dexcowin Co. observations on file

The complete Dexcowin Co. file.

All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$396

The price of the documents, added to your cart together

Sites

Also: three documents not tied to a site.

Documents

4 on file, newest first
DateDocumentPrice
2023-10-25Close-out Close-out letter$99
2023-02-23483 Form 483$99
2018-02-20Close-out Close-out letter$99
2015-08-11Close-out Close-out letter$99

Investigators on these documents

Alexandria L. Capuano (1)

FEI number 3007065358 · most recent document Oct 25, 2023

About Dexcowin Co. Ltd.

How many FDA Form 483s has Dexcowin Co. Ltd. received?

FDA Intel has 1 Form 483 on file for Dexcowin Co. Ltd.; the most recent is dated Feb 23, 2023.

When was Dexcowin Co. Ltd. last inspected by FDA?

The most recent FDA inspection document on file for Dexcowin Co. Ltd. is a Form 483 dated Feb 23, 2023, for the site in Geumcheon-gu, South Korea.

What did FDA cite at Dexcowin Co. Ltd.?

The regulations cited most in the observations on file for Dexcowin Co. Ltd. are 21 CFR 820.198(a) (Complaint files), 1 time.