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Fluence Pharma Pvt. Ltd

FDA import alert and refusal historyMumbai, IndiaFEI 3018585301

Recorded by FDA as FLUENCE PHARMA PVT. LTD

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Example subjectFluence Pharma Pvt. Lt added to Import Alert 16-129 (red list)

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As of October 25, 2026, Fluence Pharma Pvt. Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between August 13, 2026 and August 21, 2026, most often for unapproved new drug (UNAPPROVED).

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

Current status

Import alerts
Not listed
Last import refusal
Vitamin, n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Fluence Pharma Pvt. Ltd

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

2026

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry 1FX-8484185-7
    Source
  2. Import refusal
    Refused, Vitamin, n.e.c.NOT LISTEDUNAPPROVEDEntry 1FX-6463104-7
    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.

  • NOT LISTED1 refused line

    Product not listed with FDA

    The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

Questions about Fluence Pharma Pvt. Ltd

Is Fluence Pharma Pvt. Ltd on an FDA import alert?
No listing for Fluence Pharma Pvt. Ltd appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the India page.
Has FDA refused shipments from Fluence Pharma Pvt. Ltd?
Yes. FDA refused 2 shipment lines from Fluence Pharma Pvt. Ltd between August 13, 2026 and August 21, 2026. The most recent, on August 21, 2026, was vitamin, n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Fluence Pharma Pvt. Ltd's shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 2 lines) and NOT LISTED (product not listed with fda, 1 line).
What is Fluence Pharma Pvt. Ltd's FEI number?
Fluence Pharma Pvt. Ltd's FDA Establishment Identifier (FEI) is 3018585301.

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Example subjectFluence Pharma Pvt. Lt added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.