Red Dragon Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Sep 11, 2019
  • Last warning letter 2014
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Nov 6, 2014
510(k) clearances 0 None on file

Red Dragon Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Red Dragon Co., Ltd., the most recent on Nov 6, 2014.

What these totals cover: FDA records filed under the name "Red Dragon Co., Ltd." and its spelling variants "Red Dragon Co", "Red Dragon".

Latest inspection
Sep 11, 2019 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Red Dragon Co., Ltd. FDA Warning Letters

1 warning letter on Nov 6, 2014.

IssuedSubjectIssuing officeClose-out letter
Nov 6, 2014 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Jul 7, 2015 to Sep 11, 2019.

DateSiteProductClassificationFEI
Sep 11, 2019Ho Chi Minh, VietnamFood/CosmeticsNo Action Indicated (NAI)3010911934
Jul 7, 2015Ho Chi Minh, VietnamFood/CosmeticsVoluntary Action Indicated (VAI)3010911934
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Red Dragon Co., Ltd.: warning letters, injunctions and seizures. It came from FDA's Center for Tobacco Products, which regulates tobacco retailers and manufacturers. It is not a drug, medical device or food manufacturing action.

Most recent: Warning Letter, Nov 6, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3010911934Ho Chi Minh, Vietnam2Sep 11, 2019

Red Dragon Co., Ltd. and the FDA: common questions

Has Red Dragon Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Red Dragon Co., Ltd.. The most recent is dated Nov 6, 2014.

Has Red Dragon Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Red Dragon Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Red Dragon Co., Ltd.?

The most recent FDA inspection on file ended Sep 11, 2019 at Ho Chi Minh, Vietnam and was classified NAI. FDA has 2 inspections of Red Dragon Co., Ltd. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.