Nam Hai Company Ltd.
🚨 Critical Risk
FEI: 3004206311 • Ho Chi Minh City, Ho Chi Minh City • VIETNAM
FEI Number
3004206311
Location
Ho Chi Minh City, Ho Chi Minh City
Country
VIETNAMAddress
An Lac Ward, Binh Tan District, 555, Kinh Duong Vuong St., Ho Chi Minh City, Ho Chi Minh City, Vietnam
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
Score Breakdown
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
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
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.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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).
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:
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
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.
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.
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
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.
CHLORAMP
The article appears to contain a food additive, namely chloramphenicol, that is unsafe within the meaning of 21 U.S.C. 348.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
SULFITELBL
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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.
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.
INCONSPICU
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)).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
BACTERIA
The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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)).
EXCESS SUL
The article appears to contain excessive sulfites, a poisonous and deleterious substance which may render it injurious to health.
TRANSFAT
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
VETDRUGRES
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains
POIS CHLOR
The article appears to contain a poisonous or deleterious substance, namely chloramphenicol, which may render it injurious to health.
POISONORD
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 which would ordinarily render the article injurious to health. Contains:
LISTERIA
The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2025 | 16EGN02CLAMS | Division of West Coast Imports (DWCI) | |
| 11/5/2024 | 23BGD14BETEL NUT, SHELLED | 3878POISONORD | Division of West Coast Imports (DWCI) |
| 4/12/2024 | 16JGH05SHRIMP & PRAWNS | 9SALMONELLA | Division of West Coast Imports (DWCI) |
| 4/28/2023 | 25PGD03MUSHROOM, STRAW, WHOLE (BUTTON) (FUNGI) | 9SALMONELLA | Division of West Coast Imports (DWCI) |
| 9/12/2022 | 03RGT10DOUGHNUT WITHOUT CUSTARD OR CREAM FILLING | Division of Northeast Imports (DNEI) | |
| 8/2/2022 | 24HGH08PEPPER, HOT, DRIED OR PASTE | 9SALMONELLA | Division of West Coast Imports (DWCI) |
| 7/17/2019 | 03TGT02CAKES, FILLED (OTHER THAN FRUIT OR JELLY) | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 6/24/2019 | 03YGT99OTHER BAKERY PRODUCTS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/23/2019 | 21SGD12PASSION FRUIT (SUBTROPICAL AND TROPICAL FRUIT) | 241PESTICIDE | Division of West Coast Imports (DWCI) |
| 3/29/2019 | 21SGD12PASSION FRUIT (SUBTROPICAL AND TROPICAL FRUIT) | 241PESTICIDE | Division of West Coast Imports (DWCI) |
| 10/12/2017 | 02HGH01TAPIOCA STARCH PRODUCT | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
| 8/18/2017 | 28BGD49TURMERIC, GROUND, CRACKED (SPICE) | 9SALMONELLA | Division of West Coast Imports (DWCI) |
| 8/14/2017 | 21UGT48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JAMS, JELLIES, PRESERVES, MARMALADES, CANDIED, BUTTERS, SPR | 83NO PROCESS | Division of Northeast Imports (DNEI) |
| 8/1/2017 | 02HGT01TAPIOCA STARCH PRODUCT | Division of Northeast Imports (DNEI) | |
| 3/14/2017 | 31AGH03COFFEE, INSTANT | Division of West Coast Imports (DWCI) | |
| 8/24/2015 | 03YGN02CROUTONS | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 8/24/2015 | 03YGN02CROUTONS | San Francisco District Office (SAN-DO) | |
| 8/14/2015 | 03YGN99OTHER BAKERY PRODUCTS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/14/2015 | 03YGN02CROUTONS | Division of West Coast Imports (DWCI) | |
| 5/20/2015 | 28BGH49TURMERIC, GROUND, CRACKED (SPICE) | 9SALMONELLA | Division of Northeast Imports (DNEI) |
| 7/9/2014 | 16MGD03SQUID, OTHER AQUATIC SPECIES | 9SALMONELLA | Division of Northeast Imports (DNEI) |
| 7/9/2014 | 28AGD08CAPSICUMS (CAYENNE CHILI, HOT PEPPERS), WHOLE (SPICE) | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 8/21/2013 | 24TGD99LEAF & STEM VEGETABLES, N.E.C. | 241PESTICIDE | San Francisco District Office (SAN-DO) |
| 8/7/2013 | 25JCE03LEEK (A TYPE OF ONION) (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Southwest Import District Office (SWI-DO) |
| 8/5/2013 | 24TGD99LEAF & STEM VEGETABLES, N.E.C. | 241PESTICIDE | San Francisco District Office (SAN-DO) |
| 5/28/2013 | 24TGD99LEAF & STEM VEGETABLES, N.E.C. | 241PESTICIDE | San Francisco District Office (SAN-DO) |
| 3/8/2013 | 16ACT64MUD FISH | 306INSANITARY | San Francisco District Office (SAN-DO) |
| 1/24/2013 | 16AGT99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 1/15/2013 | 28BGT49TURMERIC, GROUND, CRACKED (SPICE) | 9SALMONELLA | Division of Northeast Imports (DNEI) |
| 9/13/2012 | 16ACT52GOURMAY, GOURAMI | 306INSANITARY | San Francisco District Office (SAN-DO) |
| 5/17/2012 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 5/17/2012 | 16EGN02CLAMS | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 2/8/2012 | 24FCI11CHINESE EGGPLANT, THAI EGGPLANT (FRUIT USED AS VEGETABLE) | 2040SULFITELBL | New York District Office (NYK-DO) |
| 1/5/2012 | 03MGN09FRUIT/FRUIT FLAVORED,COOKIE,BISCUIT AND WAFER DOUGH | 274COLOR LBLG | San Francisco District Office (SAN-DO) |
| 1/5/2012 | 03MGN09FRUIT/FRUIT FLAVORED,COOKIE,BISCUIT AND WAFER DOUGH | 274COLOR LBLG | San Francisco District Office (SAN-DO) |
| 11/15/2011 | 28AGT08CAPSICUMS (CAYENNE CHILI, HOT PEPPERS), WHOLE (SPICE) | 9SALMONELLA | New York District Office (NYK-DO) |
| 10/14/2011 | 16MGT14SNAILS, AQUATIC, OTHER AQUATIC SPECIES | 9SALMONELLA | New York District Office (NYK-DO) |
| 4/28/2011 | 25JGT24GINGER ROOT (ROOT & TUBER VEGETABLE) | 245EXCESS SUL | New York District Office (NYK-DO) |
| 4/6/2011 | 23ECT05COCONUT, SPREAD | 83NO PROCESS | New York District Office (NYK-DO) |
| 2/25/2011 | 33SGN99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | San Francisco District Office (SAN-DO) | |
| 2/25/2011 | 33SGN99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | San Francisco District Office (SAN-DO) | |
| 2/10/2011 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 12/20/2010 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 12/16/2010 | 37JCE99SAUCES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 11/30/2010 | 16AGT99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 11/30/2010 | 16AGT99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 11/23/2010 | 16EGN02CLAMS | 306INSANITARY | San Francisco District Office (SAN-DO) |
| 11/16/2010 | 16AGD99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 9/29/2010 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | San Francisco District Office (SAN-DO) | |
| 8/5/2010 | 24FCI01EGG PLANT (FRUIT USED AS VEGETABLE) | 2040SULFITELBL | New York District Office (NYK-DO) |
| 7/21/2010 | 16EGD04MUSSELS | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/20/2010 | 16AGT99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 5/28/2010 | 24TCT99LEAF & STEM VEGETABLES, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 5/28/2010 | 25JCT14TURNIP (ROOT & TUBER VEGETABLE) | Los Angeles District Office (LOS-DO) | |
| 5/28/2010 | 24TCT99LEAF & STEM VEGETABLES, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/29/2010 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 308MFR INSAN | San Francisco District Office (SAN-DO) |
| 3/19/2010 | 16YGH07FISH MAW, FISHERY PRODUCTS, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
| 3/19/2010 | 16AGT99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 3/15/2010 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 3/15/2010 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 3/9/2010 | 16JGD01CRAB | San Francisco District Office (SAN-DO) | |
| 2/19/2010 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 2/3/2010 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | 2580MFRHACCP | San Francisco District Office (SAN-DO) |
| 12/17/2009 | 22KGT04SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES | 3320TRANSFAT | San Francisco District Office (SAN-DO) |
| 12/14/2009 | 16MGN14SNAILS, AQUATIC, OTHER AQUATIC SPECIES | 249FILTHY | San Francisco District Office (SAN-DO) |
| 11/18/2009 | 16EGN02CLAMS | 249FILTHY | San Francisco District Office (SAN-DO) |
| 11/3/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 10/21/2009 | 16JGD05SHRIMP & PRAWNS | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 9/1/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/31/2009 | 16IJD22MACKEREL, HOT SMOKED, FISH (ONLY SCOMBEROMORUS SPP EG. SPANISH OR KING) | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/31/2009 | 16AGT99FISH, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/20/2009 | 16MGN14SNAILS, AQUATIC, OTHER AQUATIC SPECIES | 249FILTHY | San Francisco District Office (SAN-DO) |
| 7/15/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/15/2009 | 16AGD01ANCHOVY | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/15/2009 | 16AGD15EEL | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/15/2009 | 16JGD01CRAB | San Francisco District Office (SAN-DO) | |
| 7/15/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | San Francisco District Office (SAN-DO) | |
| 6/29/2009 | 16JGD01CRAB | San Francisco District Office (SAN-DO) | |
| 6/29/2009 | 16AGD73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') | San Francisco District Office (SAN-DO) | |
| 6/29/2009 | 16AGD01ANCHOVY | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD15EEL | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD15EEL | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD15EEL | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD01ANCHOVY | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD23MULLET | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16AGD10CATFISH, FRESHWATER (E.G. CHANNEL, BLUE, WHITE, YAQUI, BULLHEAD, FLATHEAD CATFISH) | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 6/29/2009 | 16JGD01CRAB | San Francisco District Office (SAN-DO) | |
| 5/8/2009 | 28FGT99MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 4/30/2009 | 16AHN01ANCHOVY | San Francisco District Office (SAN-DO) | |
| 4/23/2009 | 16CGT99FISH CAKES, BALLS, ETC., N.E.C. | San Francisco District Office (SAN-DO) | |
| 3/19/2009 | 16AGD99FISH, N.E.C. | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 11/18/2008 | 16AGT99FISH, N.E.C. | 9SALMONELLA | New York District Office (NYK-DO) |
| 9/11/2008 | 16AGT03BASS, FRESH WATER (LARGEMOUTH, SMALLMOUTH, ETC.) | 249FILTHY | San Francisco District Office (SAN-DO) |
| 9/4/2008 | 16EGT02CLAMS | 9SALMONELLA | New York District Office (NYK-DO) |
| 9/4/2008 | 16JFD01CRAB | 2900CHLORAMP | New York District Office (NYK-DO) |
| 8/22/2008 | 16EGD02CLAMS | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 7/21/2008 | 25QGT03MUSHROOM, STRAW, PIECES AND STEMS, SLICED | 2920PESTICIDES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nam Hai Company Ltd.'s FDA import refusal history?
Nam Hai Company Ltd. (FEI: 3004206311) has 266 FDA import refusal record(s) in our database, spanning from 10/16/2001 to 7/9/2025.
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. Nam Hai Company Ltd.'s FEI number is 3004206311.
What types of violations has Nam Hai Company Ltd. received?
Nam Hai Company Ltd. has been cited for 31 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 Nam Hai Company Ltd. come from?
All FDA import refusal data for Nam Hai Company Ltd. 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.