Vitromed Healthcare
FDA import alert and refusal historyJaipur, IndiaFEI 3008496443
As of October 26, 2026, Vitromed Healthcare (Jaipur, India) is on the red list of FDA Import Alert 99-42 (Foods: heavy metal (toxic element) contamination) for tulsi powder, published by FDA on March 11, 2025, and has 5 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 99-42 · red list
- Last import refusal
- Beverage base of non-fruit origin, liquid, n.e.c. · DIRECTIONS
- Last warning letter
- None found
- Last inspection
- Classified VAI (Voluntary Action Indicated)
Every FDA record for Vitromed Healthcare
7 records, newest first. Each line links to the FDA page it came from.
2025
- Import alert listingListed on Import Alert 99-42red listTulsi powderSource
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and EconSource
2018
- Import refusalSource
Refused, 3 lines in one entry: Beverage base of non-fruit origin, liquid, n.e.c.DIRECTIONSUNAPPROVEDEntry 8MQ-0004787-4Show 3 linesHide lines
- Refused, Beverage base of non-fruit origin, liquid, n.e.c.DIRECTIONSUNAPPROVEDEntry 8MQ-0004787-4Source
- Refused, Beverage base of non-fruit origin, liquid, n.e.c.DIRECTIONSUNAPPROVEDEntry 8MQ-0004787-4Source
- Refused, Beverage base of non-fruit origin, liquid, n.e.c.DIRECTIONSUNAPPROVEDEntry 8MQ-0004787-4Source
2017
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NUTRIT LBLEntry PDR-0021991-1Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NUTRIT LBLEntry PDR-0021991-1Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NUTRIT LBLEntry PDR-0021991-1Source
Refusal charges, in plain English
- DIRECTIONS3 refused lines
DIRECTIONS
- UNAPPROVED3 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.
- 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.
Questions about Vitromed Healthcare
- Is Vitromed Healthcare on an FDA import alert?
- Yes. As of October 26, 2026, Vitromed Healthcare is on the red list of FDA Import Alert 99-42, “Foods: heavy metal (toxic element) contamination”, for tulsi powder; FDA published the listing on March 11, 2025.
- Has FDA refused shipments from Vitromed Healthcare?
- Yes. FDA refused 5 shipment lines from Vitromed Healthcare between July 11, 2017 and February 26, 2018. The most recent, on February 26, 2018, was beverage base of non-fruit origin, liquid, n.e.c., charged as DIRECTIONS (directions).
- Why did FDA refuse Vitromed Healthcare's shipments?
- The most frequent charges are DIRECTIONS (directions, 3 lines) and UNAPPROVED (unapproved new drug, 3 lines).
- When was Vitromed Healthcare last inspected by FDA?
- FDA's most recent inspection of Vitromed Healthcare with a final classification is dated March 5, 2025 and was classified VAI (Voluntary Action Indicated).
- What is Vitromed Healthcare's FEI number?
- Vitromed Healthcare's FDA Establishment Identifier (FEI) is 3008496443.
- Can shipments from Vitromed Healthcare still enter the U.S.?
- Shipments of tulsi powder from Vitromed Healthcare can be detained without physical examination under Import Alert 99-42; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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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.