Bipha Drug Laboratories
FDA import alert and refusal historyKottayam, IndiaFEI 3004816333
Recorded by FDA as BIPHA DRUG LABORATORIES
As of October 26, 2026, Bipha Drug Laboratories is not on any FDA import alert in SupplierRadar's records; FDA refused 3 of its shipment lines between August 6, 2019 and July 20, 2022, most often for not identified as a dietary supplement (DIETARYLBL).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Ashwagandha (herbal & botanicals, not teas) · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Bipha Drug Laboratories
3 records, newest first. Each line links to the FDA page it came from.
2022
- Import refusalRefused, Ashwagandha (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-1423564-0Source
2019
- Import refusalRefused, Valerian (herbal & botanicals ii)LIST INGREDIETARYLBLNCONTACTNUTRIT LBLEntry AEK-6555618-2Source
- Import refusalRefused, Valerian (herbal & botanicals, not teas ii)DIETARYLBLDIETARYINGPLANT PARTNCONTACTNUTRIT LBLEntry AEK-6101052-3Source
Refusal charges, in plain English
- DIETARYLBL2 refused lines
Not identified as a dietary supplement
The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).
- NCONTACT2 refused lines
No U.S. adverse event contact on supplement label
The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.
- NUTRIT LBL2 refused lines
Nutrition information missing from label
The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.
- DIETARYING1 refused line
Dietary ingredients not listed
The dietary supplement label appeared not to list each dietary ingredient and its quantity, or the total quantity of a proprietary blend.
- LIST INGRE1 refused line
Ingredients not listed
The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).
- PLANT PART1 refused line
PLANT PART
- 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 Bipha Drug Laboratories
- Is Bipha Drug Laboratories on an FDA import alert?
- No listing for Bipha Drug 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 Bipha Drug Laboratories?
- Yes. FDA refused 3 shipment lines from Bipha Drug Laboratories between August 6, 2019 and July 20, 2022. The most recent, on July 20, 2022, was ashwagandha (herbal & botanicals, not teas), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Bipha Drug Laboratories's shipments?
- The most frequent charges are DIETARYLBL (not identified as a dietary supplement, 2 lines) and NCONTACT (no u.s. adverse event contact on supplement label, 2 lines).
- What is Bipha Drug Laboratories's FEI number?
- Bipha Drug Laboratories's FDA Establishment Identifier (FEI) is 3004816333.
Buying from Bipha Drug Laboratories?
Watch it and get the FDA record the day it changes. Free for one supplier.
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.