Embotelladora Femsa, S.A. De C.V.

⚠️ Moderate Risk

FEI: 3003228645 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3003228645

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO

🏢

Address

Guillermo Haro No 600 7, Pueblo Lomas De Nuevo Mexico, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

36.3

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

12/10/2010

Latest Refusal

2/13/2004

Earliest Refusal

Score Breakdown

Violation Severity

58.1×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

14.7×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

118×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2744×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3202×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2182×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3211×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3281×

USUAL NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

3191×

WRONG IDEN

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food.

Refusal History

Date	Product	Violations	Division
12/10/2010	29BGT99CARBONATED SOFT DRINK, N.E.C.	11UNSAFE COL 274COLOR LBLG	New York District Office (NYK-DO)
1/15/2010	29BGT99CARBONATED SOFT DRINK, N.E.C.	11UNSAFE COL	New York District Office (NYK-DO)
11/5/2009	29BGT99CARBONATED SOFT DRINK, N.E.C.	11UNSAFE COL	New York District Office (NYK-DO)
6/29/2005	29BCT50SOFT DRINK, COLA, CARBONATED	218LIST INGRE 320LACKS FIRM 321LACKS N/C 328USUAL NAME 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
2/9/2005	29BCY50SOFT DRINK, COLA, CARBONATED	11UNSAFE COL 218LIST INGRE 274COLOR LBLG 320LACKS FIRM 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
1/20/2005	29BCT50SOFT DRINK, COLA, CARBONATED	11UNSAFE COL	Southwest Import District Office (SWI-DO)
11/9/2004	29BCY02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED	11UNSAFE COL	Southwest Import District Office (SWI-DO)
3/25/2004	29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED	11UNSAFE COL 274COLOR LBLG	Southwest Import District Office (SWI-DO)
2/17/2004	29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED	11UNSAFE COL 274COLOR LBLG	Southwest Import District Office (SWI-DO)
2/13/2004	29BCT09SOFT DRINK, OTHER FRUIT FLAVORED, CARBONATED	319WRONG IDEN	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Embotelladora Femsa, S.A. De C.V.'s FDA import refusal history?

Embotelladora Femsa, S.A. De C.V. (FEI: 3003228645) has 10 FDA import refusal record(s) in our database, spanning from 2/13/2004 to 12/10/2010.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Embotelladora Femsa, S.A. De C.V.'s FEI number is 3003228645.

What types of violations has Embotelladora Femsa, S.A. De C.V. received?

Embotelladora Femsa, S.A. De C.V. has been cited for 8 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Embotelladora Femsa, S.A. De C.V. come from?

All FDA import refusal data for Embotelladora Femsa, S.A. De C.V. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.