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GL Biochem (Shanghai) Ltd

FDA import alert and refusal historyShanghai, ChinaFEI 3007554486

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Example subjectGL Biochem (Shanghai) Lt added to Import Alert 16-129 (red list)

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As of October 26, 2026, GL Biochem (Shanghai) Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on August 12, 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
Protein n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for GL Biochem (Shanghai) Ltd

1 record, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, Protein n.e.c.UNAPPROVEDEntry 300-3744048-7
    Source

Refusal charges, in plain English

  • UNAPPROVED1 refused line

    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 GL Biochem (Shanghai) Ltd

Is GL Biochem (Shanghai) Ltd on an FDA import alert?
No listing for GL Biochem (Shanghai) Ltd appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the China page.
Has FDA refused shipments from GL Biochem (Shanghai) Ltd?
Yes. FDA refused 1 shipment line from GL Biochem (Shanghai) Ltd on August 12, 2026. The most recent, on August 12, 2026, was protein n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse GL Biochem (Shanghai) Ltd's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
What is GL Biochem (Shanghai) Ltd's FEI number?
GL Biochem (Shanghai) Ltd's FDA Establishment Identifier (FEI) is 3007554486.

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Example subjectGL Biochem (Shanghai) 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.