ImportRefusal LogoImportRefusal

Dulces Vero

⚠️ High Risk

FEI: 3004077681 • Guadalajara, Jalisco • MEXICO

FEI

FEI Number

3004077681

📍

Location

Guadalajara, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Calle 26 #2395 zona Industrial, , Guadalajara, Jalisco, Mexico

High Risk

FDA Import Risk Assessment

73.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

245
Total Refusals
13
Unique Violations
3/14/2017
Latest Refusal
9/8/2005
Earliest Refusal

Score Breakdown

Violation Severity
92.6×40%
Refusal Volume
88.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

249217×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

340026×

PB-FOOD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.

3248×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

2518×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

2185×

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.

2385×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

4824×

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.

113×

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).

33002×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2742×

COLOR LBLG

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

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.

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.

Refusal History

DateProductViolationsDivision
3/14/2017
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
2/10/2012
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
9/2/2011
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/21/2011
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/8/2011
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
6/8/2011
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
5/9/2011
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
238UNSAFE ADD
251POISONOUS
Southwest Import District Office (SWI-DO)
3/4/2011
33CGE99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
3/4/2011
33SGE06LOLLIPOP (WITHOUT CHOCOLATE)
238UNSAFE ADD
251POISONOUS
Southwest Import District Office (SWI-DO)
3/3/2011
33SGE06LOLLIPOP (WITHOUT CHOCOLATE)
238UNSAFE ADD
251POISONOUS
Southwest Import District Office (SWI-DO)
3/3/2011
33SGE06LOLLIPOP (WITHOUT CHOCOLATE)
238UNSAFE ADD
251POISONOUS
Southwest Import District Office (SWI-DO)
11/10/2010
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
11/10/2010
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
11/10/2010
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/15/2010
33LGT09MARSHMALLOW CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
10/8/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/8/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/3/2010
33SGE06LOLLIPOP (WITHOUT CHOCOLATE)
218LIST INGRE
274COLOR LBLG
Southwest Import District Office (SWI-DO)
9/3/2010
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
7/16/2010
33YGY99CANDY WITHOUT CHOCOLATE N.E.C.
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
7/1/2010
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/25/2010
33EGT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
4/20/2010
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
249FILTHY
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
4/16/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
251POISONOUS
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
251POISONOUS
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
3/23/2010
33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
3/9/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
2/8/2010
33EGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
2/8/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/11/2010
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/21/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/21/2009
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/21/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/21/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/17/2009
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/17/2009
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/17/2009
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/15/2009
33LGY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/8/2009
33LGY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/8/2009
33LGY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
11/27/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
11/17/2009
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
11/17/2009
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
11/13/2009
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
10/28/2009
33LGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33UGT99CHEWING GUM, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/28/2009
33LGT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/8/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/8/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
10/8/2009
33SDT06LOLLIPOP (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
9/29/2009
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/25/2009
33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Dulces Vero's FDA import refusal history?

Dulces Vero (FEI: 3004077681) has 245 FDA import refusal record(s) in our database, spanning from 9/8/2005 to 3/14/2017.

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. Dulces Vero's FEI number is 3004077681.

What types of violations has Dulces Vero received?

Dulces Vero has been cited for 13 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 Dulces Vero come from?

All FDA import refusal data for Dulces Vero 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.