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Facility profile

Zhejiang Huahai Pharmaceutical Co., Ltd.

Drug product manufacturing · Active pharmaceutical ingredient (API) manufacturing · Zhejiang 317024 · China

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed2 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Active pharmaceutical ingredient (API) manufactureManufacture
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Jan 24, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Jun 2025

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history7 inspection records

FDA inspection history

7 records, Sep 2010 – Jan 2025 · 4 NAI · 1 VAI · 2 OAI

DateClassProject areaCitationsFY
Jan 24, 2025OAIDrug Quality Assurance2025
Jul 2, 2021NAIDrug Quality Assurance2021
May 31, 2019OAIDrug Quality Assurance2019
Nov 18, 2016VAIDrug Quality Assurance2017
Mar 27, 2015NAIDrug Quality Assurance2015
Aug 9, 2013NAIDrug Quality Assurance2013
Sep 2, 2010NAIDrug Quality Assurance2010

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Jun 6, 2025Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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