Guangzhou Health & Health Medical Equipment Co., Ltd. FDA Record

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

  • Latest inspection OAI · Mar 21, 2019
  • No warning letters matched by name
Inspections 1 1 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Guangzhou Health & Health Medical Equipment Co., Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Guangzhou Health & Health Medical Equipment Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Guangzhou Health & Health Medical Equipment Co., Ltd." and its spelling variant "Guangzhou Health And Health Medical Equipment Co".

Latest inspection
Mar 21, 2019 · OAI

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
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Mar 21, 2019.

DateSiteProductClassificationFEI
Mar 21, 2019Guangzhou, ChinaDevicesOfficial Action Indicated (OAI)3000163458
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3000163458Guangzhou, China1Mar 21, 2019

Guangzhou Health & Health Medical Equipment Co., Ltd. and the FDA: common questions

Has Guangzhou Health & Health Medical Equipment Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Guangzhou Health & Health Medical Equipment Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Guangzhou Health & Health Medical Equipment Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Guangzhou Health & Health Medical Equipment Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Guangzhou Health & Health Medical Equipment Co., Ltd.?

The most recent FDA inspection on file ended Mar 21, 2019 at Guangzhou, China and was classified OAI. FDA has 1 inspection of Guangzhou Health & Health Medical Equipment Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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