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SM BIOMED SDN.BHD. — FDA Facility Profile

FEI 3005983287

SM BIOMED SDN.BHD. is an FDA-registered facility (FEI 3005983287) located in Malaysia (MYS). Registered operations: API MANUFACTURE. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 28, 2023: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
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
2

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
Jul 28, 2023Voluntary Action Indicated (VAI)No citations listed
Mar 23, 2018Voluntary Action Indicated (VAI)No citations listed
Mar 11, 2016Voluntary Action Indicated (VAI)No citations listed
Mar 7, 2013Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
SM Biomed Sdn Bhd
Location
Malaysia (MYS)
Registration Expires
Dec 31, 2026
Operations
API MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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