Has FDA refused shipments from Sirio Healthcare (Anhui) Co., Ltd?

Yes. FDA refused 4 shipment lines from Sirio Healthcare (Anhui) Co., Ltd between March 1, 2023 and November 5, 2024. The most recent, on November 5, 2024, was multiple vitamins (mvi-12 vitamin combo) (vitamin), charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Sirio Healthcare (Anhui) Co., Ltd's shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 4 lines) and COLOR LBLG (artificial coloring not declared, 2 lines).

What is Sirio Healthcare (Anhui) Co., Ltd's FEI number?

Sirio Healthcare (Anhui) Co., Ltd's FDA Establishment Identifier (FEI) is 3014277459.

Can shipments from Sirio Healthcare (Anhui) Co., Ltd still enter the U.S.?

Shipments of multivitamin pectin gummy (super greens gummy); eye care lutein gummy 3000 (mixed berry flavor); vitamin c&d 3000 green grape flavor from Sirio Healthcare (Anhui) Co., Ltd can be detained without physical examination under Import Alert 45-02; 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).

Sirio Healthcare (Anhui) Co., Ltd

FDA import alert and refusal historyMaanshan, ChinaFEI 3014277459

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As of October 26, 2026, Sirio Healthcare (Anhui) Co., Ltd (Maanshan, China) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for multivitamin pectin gummy (super greens gummy); eye care lutein gummy 3000 (mixed berry flavor); vitamin c&d 3000 green grape flavor, published by FDA on March 8, 2023, and has 4 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked October 26, 2026. Request a correction

Current status

Import alerts: IA 45-02 · red list
Last import refusal: Nov 5, 2024Multiple vitamins (mvi-12 vitamin combo) (vitamin) · UNSAFE COL
Last warning letter: None found
Last inspection: None on record

Every FDA record for Sirio Healthcare (Anhui) Co., Ltd

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

2024

Nov 5, 2024Import refusal
Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNSAFE COLEntry TZ6-6136983-3
Source
Feb 23, 2024Import refusal
Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSAFE COLEntry SCS-1270460-1
Source

2023

Mar 8, 2023Import alert listing
Listed on Import Alert 45-02red listMULTIVITAMIN PECTIN GUMMY (Super Greens Gummy); EYE CARE LUTEIN GUMMY 3000 (Mixed Berry Flavor); VITAMIN C&D 3000 GREEN GRAPE FLAVOR
Source
Mar 1, 2023Import refusal
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSAFE COLCOLOR LBLGEntry E8L-2213022-8Show 2 linesHide lines
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSAFE COL COLOR LBLGEntry E8L-2213022-8Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSAFE COL COLOR LBLGEntry E8L-2213022-8Source
Source

Refusal charges, in plain English

UNSAFE COL4 refused lines
Color additive unsafe under section 721
The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.
COLOR LBLG2 refused lines
Artificial coloring not declared
The product appeared to contain an artificial coloring without labeling that states that fact.

Questions about Sirio Healthcare (Anhui) Co., Ltd

Is Sirio Healthcare (Anhui) Co., Ltd on an FDA import alert?: Yes. As of October 26, 2026, Sirio Healthcare (Anhui) Co., Ltd is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for multivitamin pectin gummy (super greens gummy); eye care lutein gummy 3000 (mixed berry flavor); vitamin c&d 3000 green grape flavor; FDA published the listing on March 8, 2023.
Has FDA refused shipments from Sirio Healthcare (Anhui) Co., Ltd?: Yes. FDA refused 4 shipment lines from Sirio Healthcare (Anhui) Co., Ltd between March 1, 2023 and November 5, 2024. The most recent, on November 5, 2024, was multiple vitamins (mvi-12 vitamin combo) (vitamin), charged as UNSAFE COL (color additive unsafe under section 721).
Why did FDA refuse Sirio Healthcare (Anhui) Co., Ltd's shipments?: The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 4 lines) and COLOR LBLG (artificial coloring not declared, 2 lines).
What is Sirio Healthcare (Anhui) Co., Ltd's FEI number?: Sirio Healthcare (Anhui) Co., Ltd's FDA Establishment Identifier (FEI) is 3014277459.
Can shipments from Sirio Healthcare (Anhui) Co., Ltd still enter the U.S.?: Shipments of multivitamin pectin gummy (super greens gummy); eye care lutein gummy 3000 (mixed berry flavor); vitamin c&d 3000 green grape flavor from Sirio Healthcare (Anhui) Co., Ltd can be detained without physical examination under Import Alert 45-02; 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.