Shandong Haiyan Medical Manufacture Co., Ltd. FDA Inspection Record

FEI 3009525820 · Inspections, Form 483s, warning letters and import refusals

Shandong Haiyan Medical Manufacture Co., Ltd. is an FDA-registered facility (FEI 3009525820) located in Shandong, CN. Registered operations: MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 25, 2025: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 25, 2025No Action Indicated (NAI)No citations listed
Mar 16, 2018No Action Indicated (NAI)No citations listed
Aug 5, 2016Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Shandong Haiyan Medical Manufacture Co., Ltd.
Location
Shandong (CN)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

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