Uttam Laboratories
FDA import alert and refusal historyKarnal, IndiaFEI 3004655396
As of October 26, 2026, Uttam Laboratories is not on any FDA import alert in SupplierRadar's records; FDA refused 5 of its shipment lines on September 11, 2025, 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
- Amla (herbal & botanicals, not teas ii) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Uttam Laboratories
5 records, newest first. Each line links to the FDA page it came from.
2025
- Import refusalSource
Refused, 5 lines in one entry: Amla (herbal & botanicals, not teas ii); Gymnema sylvestre (herbal & botanicals, not teas) and 3 moreUNAPPROVEDEntry 799-1551417-0Show 5 linesHide lines
- Refused, Amla (herbal & botanicals, not teas ii)UNAPPROVEDEntry 799-1551417-0Source
- Refused, Gymnema sylvestre (herbal & botanicals, not teas)UNAPPROVEDEntry 799-1551417-0Source
- Refused, Tribulus (herbal & botanicals, not teas)UNAPPROVEDEntry 799-1551417-0Source
- Refused, Dl-methionine (not for infant foods) (protein)UNAPPROVEDEntry 799-1551417-0Source
- Refused, Valerian (herbal & botanicals, not teas ii)UNAPPROVEDEntry 799-1551417-0Source
Refusal charges, in plain English
- UNAPPROVED5 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 Uttam Laboratories
- Is Uttam Laboratories on an FDA import alert?
- No listing for Uttam Laboratories 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 Uttam Laboratories?
- Yes. FDA refused 5 shipment lines from Uttam Laboratories on September 11, 2025. The most recent, on September 11, 2025, was amla (herbal & botanicals, not teas ii), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Uttam Laboratories's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 5 lines).
- What is Uttam Laboratories's FEI number?
- Uttam Laboratories's FDA Establishment Identifier (FEI) is 3004655396.
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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.