Drug establishmentActive, Registered FY2026FDA warning letter on file

FEI FAH MEDICAL MANUFACTURING PTE LTD

FEI FAH MEDICAL MANUFACTURING PTE LTD is an FDA-registered drug establishment (FEI 3003892002) located in . The facility is active, registered for FY2026. Its most recent FDA inspection on record (2015-12-09) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Jan 30, 2023

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

3003892002

Address

61 KAKI BUKIT AVE 1, ,

Establishment type

Drug establishment

Products / operations

Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Dec 9, 2015 · Voluntary Action Indicated (VAI)
Mar 8, 2013 · Voluntary Action Indicated (VAI)

Form 483 observations

Dec 9, 2015, 4 observations: Adequate number of batches on stability; Rejecting When Specifications Not Met; Scientifically sound laboratory controls

Questions

Is FEI FAH MEDICAL MANUFACTURING PTE LTD registered with the FDA?

Yes. FEI FAH MEDICAL MANUFACTURING PTE LTD is an FDA-registered drug establishment (FEI 3003892002) in . Its current registration status is Active, Registered FY2026.

Has FEI FAH MEDICAL MANUFACTURING PTE LTD received an FDA warning letter?

Yes. FDA issued a warning letter to FEI FAH MEDICAL MANUFACTURING PTE LTD; the most recent is dated Jan 30, 2023 (CGMP/Finished Pharmaceuticals/Adulterated).

What does FEI FAH MEDICAL MANUFACTURING PTE LTD do?

FEI FAH MEDICAL MANUFACTURING PTE LTD's FDA-registered operations are: Manufacturing.

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Source: FDA public data · status as of 2026-06-06