Zhejiang Huahai Pharmaceutical Co., Ltd. FDA Record

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

Zhejiang Huahai Pharmaceutical Co., Ltd. has 0 FDA recalls, 14 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Zhejiang Huahai Pharmaceutical Co., Ltd., the most recent on Jun 6, 2025. FDA has published 5 Form 483s for Zhejiang Huahai Pharmaceutical Co., Ltd..

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

Latest inspection
Apr 24, 2026 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections14Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Zhejiang Huahai Pharmaceutical Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Zhejiang Huahai Pharmaceutical Co., Ltd.: FDA inspections per year 2017: 1 inspections120172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 2 inspections220212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 1 inspections120252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202611000
202511100
202410000
202300000
202200000
202120000
202000000
201911000
201811100
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Zhejiang Huahai Pharmaceutical Co., Ltd. FDA Warning Letters

2 warning letters from Nov 29, 2018 to Jun 6, 2025.

IssuedSubjectIssuing officeClose-out letter
Jun 6, 2025 · Letter on fda.gov CGMP/Finished Pharmaceuticals/AdulteratedOffice of Manufacturing Quality
Nov 29, 2018 · 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.

Zhejiang Huahai Pharmaceutical Co., Ltd. Form 483s

5 Form 483s published by FDA.

DateDocumentFEI
Apr 24, 2026 · Document on fda.gov 4833003999190
Apr 16, 2025 · Document on fda.gov 4833003999190
Nov 20, 2024 · Document on fda.gov 4833003885745
May 19, 2017 · Document on fda.gov 4833003885745
Nov 18, 2016 · Document on fda.gov 4833003999190

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

14 inspections from Sep 2, 2010 to Apr 24, 2026.

DateSiteProductClassificationFEI
Apr 24, 2026Linhai, ChinaDrugsOfficial Action Indicated (OAI)3003999190
Jan 24, 2025Linhai, ChinaDrugsOfficial Action Indicated (OAI)3003999190
Nov 20, 2024Linhai, ChinaDrugsVoluntary Action Indicated (VAI)3003885745
Jul 29, 2021Linhai, ChinaDrugsNo Action Indicated (NAI)3003885745
Jul 2, 2021Linhai, ChinaDrugsNo Action Indicated (NAI)3003999190
May 31, 2019Linhai, ChinaDrugsOfficial Action Indicated (OAI)3003999190
Aug 3, 2018Linhai, ChinaDrugsOfficial Action Indicated (OAI)3003885745
May 19, 2017Linhai, ChinaDrugsVoluntary Action Indicated (VAI)3003885745
Nov 18, 2016Linhai, ChinaDrugsVoluntary Action Indicated (VAI)3003999190
Mar 27, 2015Linhai, ChinaDrugsNo Action Indicated (NAI)3003999190
May 23, 2014Linhai, ChinaDrugsNo Action Indicated (NAI)3003885745
Aug 9, 2013Linhai, ChinaDrugsNo Action Indicated (NAI)3003999190
Sep 8, 2010Linhai, ChinaDrugsNo Action Indicated (NAI)3003885745
Sep 2, 2010Linhai, ChinaDrugsNo Action Indicated (NAI)3003999190
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 2 compliance actions under Zhejiang Huahai Pharmaceutical Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 6, 2025.

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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003999190Linhai, China8Apr 24, 2026
FEI 3003885745Linhai, China6Nov 20, 2024

Zhejiang Huahai Pharmaceutical Co., Ltd. and the FDA: common questions

Has Zhejiang Huahai Pharmaceutical Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Zhejiang Huahai Pharmaceutical Co., Ltd.. The most recent is dated Jun 6, 2025, with the subject "CGMP/Finished Pharmaceuticals/Adulterated".

Has Zhejiang Huahai Pharmaceutical Co., Ltd. received an FDA Form 483?

FDA has published 5 Form 483s for Zhejiang Huahai Pharmaceutical Co., Ltd. in its reading room, the most recent dated Apr 24, 2026. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Zhejiang Huahai Pharmaceutical Co., Ltd.?

The most recent FDA inspection on file ended Apr 24, 2026 at Linhai, China and was classified OAI. FDA has 14 inspections of Zhejiang Huahai Pharmaceutical Co., Ltd. on file, 4 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.