Is OM Pharmaceuticals on an FDA import alert?

No listing for OM Pharmaceuticals appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.

Has FDA refused shipments from OM Pharmaceuticals?

Yes. FDA refused 2 shipment lines from OM Pharmaceuticals between February 17, 2026 and February 20, 2026. The most recent, on February 20, 2026, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse OM Pharmaceuticals's shipments?

The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).

When was OM Pharmaceuticals last inspected by FDA?

FDA's most recent inspection of OM Pharmaceuticals with a final classification is dated May 18, 2018 and was classified NAI (No Action Indicated).

What is OM Pharmaceuticals's FEI number?

OM Pharmaceuticals's FDA Establishment Identifier (FEI) is 3004125536.

OM Pharmaceuticals

FDA import alert and refusal historyBangalore, IndiaFEI 3004125536

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As of October 26, 2026, OM Pharmaceuticals is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between February 17, 2026 and February 20, 2026, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked October 26, 2026. Request a correction

Current status

Import alerts: Not listed
Last import refusal: Feb 20, 2026Herbals & botanicals (not teas), n.e.c. · UNAPPROVED
Last warning letter: None found
Last inspection: May 18, 2018Classified NAI (No Action Indicated)

Every FDA record for OM Pharmaceuticals

3 records, newest first. Each line links to the FDA page it came from.

2026

Feb 20, 2026Import refusal
Refused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry AEK-9441399-2
Source
Feb 17, 2026Import refusal
Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 799-9354747-3
Source

2018

May 18, 2018Inspection
Inspection classified NAI (No Action Indicated)Food Composition, Standards, Labeling and Econ
Source

Refusal charges, in plain English

UNAPPROVED2 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about OM Pharmaceuticals

Is OM Pharmaceuticals on an FDA import alert?: No listing for OM Pharmaceuticals appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.
Has FDA refused shipments from OM Pharmaceuticals?: Yes. FDA refused 2 shipment lines from OM Pharmaceuticals between February 17, 2026 and February 20, 2026. The most recent, on February 20, 2026, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse OM Pharmaceuticals's shipments?: The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
When was OM Pharmaceuticals last inspected by FDA?: FDA's most recent inspection of OM Pharmaceuticals with a final classification is dated May 18, 2018 and was classified NAI (No Action Indicated).
What is OM Pharmaceuticals's FEI number?: OM Pharmaceuticals's FDA Establishment Identifier (FEI) is 3004125536.

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