What is an Import Alert?
An Import Alert is FDA’s way of telling the world that the Agency thinks your products present safety problems. As a result of an
Import Alert, FDA will automatically detain your products at the border, costing your customers a lot of money. More technically, FDA
Import Alerts are issued whenever FDA determines that it already has sufficient evidence to conclude that your products appear to be
adulterated, misbranded, or unapproved, and that therefore they may be refused admission. Many products listed on import alert can
still be imported into the USA. However, the import process will be more expensive for the importer, which will reduce the amount of
money the importer is willing to pay for the product. Also, if FDA refuses the shipment because the importer decides not to bother
trying to reverse an FDA automatic detention, or because the importer or private lab or customs broker fails to meet a simple
deadline, the refused shipment will have to be exported or destroyed. In severe cases, FDA might ask Customs to seize the imported
products.
What are the Different Types of Import Alerts?
There are many types of Import Alerts, both in terms of scope and impact, but also in terms of affected countries, regions, companies
and product industries. The largest and most active Import Alerts affect seafood, cosmetics, fruits and vegetables, color additives,
dietary supplements, pesticide residues in foods, bakery items, active pharmaceutical ingredients (drugs), latex gloves and condoms
(medical devices). Very few Import Alerts apply to only a single company. There is even an Import Alert specifically for companies that
refuse an FDA facility inspection (new authority given to FDA under the Food Safety Modernization Act (FSMA)).
How is a Firm Added to an Import Alert?
most Import Alert recommendations come from the FDA compliance officer who found the problem originally, they
can come from many more sources, including FDA inspectors, federal, state or local agencies, foreign or other government authorities,
press releases, and industry complaints. DIO reviews the recommendation, the supporting evidence, and current and past national
detention data to determine whether Automatic Detention or DWPE is appropriate. DIO sometimes refers the recommendation to
one of FDA’s six Product Centers (Foods, Drugs, Devices, Biologics, Vet Medicine, or Tobacco). If FDA concludes that the
recommendation is appropriate, DIO will either add the manufacturer, importer, or product to an existing Import Alert, or create a
new one. The company and product will then appear on the Import Alert’s “Red List.”
Most Common Import Alerts
99-19:
Salmonella
in food products
53-06: Illegal/undeclared colors in cosmetics
45-02: Illegal/undeclared colors in foods
16-81:
Salmonella
in seafood and other food products
66-41: Unapproved new drugs
COUNTRY WISE IMPORT ALERTS OF ALL FOOD, DRUG & MEDICAL DEVICES
Country/Area Count Country/Area Count Country/Area Count Country/Area Count
CHINA 77 PORTUGAL 15 C�TE D�IVOIRE 5 MAURITIUS 2
CANADA 65 VENEZUELA 15 GUYANA 5 MOLDOVA 2
MEXICO 65 ARGENTINA 14 JORDAN 5 PARAGUAY 2
MULTIPLE COUNTRIES (PODS ONLY) 62 BANGLADESH 12 KENYA 5 SENEGAL 2
HONG KONG 50 GUATEMALA 12 LITHUANIA 5 SIERRA LEONE 2
INDIA 47 HUNGARY 12 OMAN 5 TANZANIA, UNITED REPUBLIC OF 2
THAILAND 47 SWEDEN 12 ROMANIA 5 VANUATU 2
TAIWAN 45 BULGARIA 11 SERBIA 5 AMERICAN SAMOA 1
UNITED KINGDOM 42 EL SALVADOR 11 SLOVAKIA 5 ANTIGUA & BARBUDA 1
JAPAN 40 IRELAND 11 SURINAM 5 ARUBA 1
GERMANY 35 UNITED ARAB EMIRATES 11 ALBANIA 4 AZERBAIJAN 1
KOREA, REPUBLIC OF (SOUTH) 35 FIJI 10 ARMENIA 4 BAHRAIN 1
ITALY 33 JAMAICA 10 BOSNIA-HERCEGOVINA 4 BERMUDA 1
FRANCE 31 NICARAGUA 10 BRITISH VIRGIN ISLANDS 4 BURKINA FASO 1
VIETNAM 31 NIGERIA 10 CYPRUS 4 BURMA 1
SPAIN 30 PANAMA 10 MONACO 4 CAMBODIA 1
INDONESIA 29 AUSTRIA 9 NETHERLANDS ANTILLES 4 COOK ISLANDS 1
BRAZIL 27 BAHAMAS 9 SLOVENIA 4 ETHIOPIA 1
PHILIPPINES 27 EGYPT 9 ANDORRA 3 FALKLAND ISLANDS 1
MALAYSIA 26 FINLAND 9 BELIZE 3 FAROE ISLANDS 1
PERU 24 HAITI 9 CZECHOSLOVAKIA (DO NOT USE) 3 FRENCH POLYNESIA 1
TURKEY 22 HONDURAS 9 DOMINICA 3 GAMBIA, THE 1
UNITED STATES 22 LEBANON 9 ESTONIA 3 GIBRALTAR 1
NETHERLANDS 21 MOROCCO 9 GRENADA 3 GUADELOUPE 1
PAKISTAN 21 LATVIA 8 LIECHTENSTEIN 3 KAMPUCHEA 1
SINGAPORE 21 NORWAY 8 SAN MARINO 3 MADAGASCAR 1
COLOMBIA 20 SAUDI ARABIA 8 SEYCHELLES 3 MONGOLIA 1
ISRAEL 20 SRI LANKA 8 TUNISIA 3 NAMIBIA 1
SOUTH AFRICA 20 URUGUAY 8 AFGHANISTAN 2 PALAU 1
COSTA RICA 19 GHANA 7 ALGERIA 2 ST. VINCENT & THE GRENADINES 1
DOMINICAN REPUBLIC 19 IRAN 7 BARBADOS 2 SUDAN 1
AUSTRALIA 18 UKRAINE 7 BELARUS 2 SWAZILAND 1
CHILE 18 YUGOSLAVIA 7 BURMA (MYANMAR) 2 TOGO 1
ECUADOR 17 CZECH REPUBLIC 6 BYELARUS 2 TONGA 1
RUSSIA 17 LUXEMBOURG 6 CAYMAN ISLANDS 2 TURKS & CAICOS ISLAND 1
SWITZERLAND 17 MACEDONIA 6 GEORGIA 2 UGANDA 1
BELGIUM 16 SYRIAN ARAB REPUBLIC 6 GUINEA 2 UNITED STATES OUTLYING ISLANDS 1
DENMARK 16 TRINIDAD & TOBAGO 6 ICELAND 2 WESTERN SAMOA 1
POLAND 16 BOLIVIA 5 MACAU 2 ZIMBABWE 1
GREECE 15 CAMEROON 5 MALTA & GOZO 2
IMPORT ALERTS RELATED TO DRUGS IN INDIA
55-05 DWPE 08/06/2013 DETENTION WITHOUT PHYSICAL EXAMINATION OF FINISHED
DOSAGE DRUG PRODUCTS, ACTIVE PHARMACEUTICAL
INGREDIENTS AND INACTIVE INGREDIENTS FOR POTENTIALLY HAZARDOUS MICROBIOLOGICAL CONTAMINATION
66-40 DWPE 09/13/2013 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41 DWPE 09/11/2013 Detention Without Physical Examination of Unapproved New Drugs
Promoted In The U.S.
66-57 DWPE 12/14/2012 "Detention Without Physical Examination Of Foreign manufactured Unapproved Prescription Drugs Promoted to Individuals in the U.S."
Import Alert Name:
"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
Reason for Alert:
*** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when
an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).
Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or
other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices
warranting detention of either particular products or all products manufactured by a firm.
DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by
reinspection or submission of appropriate documentation to the responsible FDA Center. ***
Guidance:
*** Districts may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of
this import alert.
Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to
adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency
will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control of
pharmaceutical products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B)."
S.No. Details of Indian Firm
1 Amsal Chem Pvt. Ltd. Date Published : 04/11/2013 A-1/401-402-403, GIDC , Ankleshwar, Gujarat, INDIA
2 Aurobindo Pharma Limited, Unit VIDate Published : 02/07/2011
Survey No. 329/39 & 329/47 , Chitkul Village , Hyderabad, Andhra Pradesh INDIA 3 Fleming Laboratories Date Published : 04/08/2011
Survey No: 270 (Old no.: 364/1), , Kanukunta Road , Navabpet Village, Sivampet Mandal, Medak District- Andhra Pradesh INDIA 4 Fleming Laboratories Limited Date Published : 04/11/2011
Plot No. 48, Temple Rock Enclave , Tarbund X Road , Secunderabad, INDIA 5 Global Calcium Private Limited Date Published : 08/06/2013
No. 19 & 19B, Sipcot Industrial Complex , Krishnagiri District , Hosur, Tamil Nadu INDIA 6 Global Calcium PvtDate Published : 08/06/2013
Box 3411 , Bangalore, INDIA
7 Global Calcium Pvt LtdDate Published : 08/06/2013 No 1 2 Nd Floor 17th Main , Bangalore bangalore, INDIA 8 Global Calcium Pvt Ltd Date Published : 08/06/2013
711 Karomangala 111 Block , Bangalore, INDIA
9 Global Calcium Pvt. Limited Date Published : 08/06/2013 125/126 Sipcot Industrial Complex , Hosur, Tamil Nadu INDIA 10 Kamud Drugs Pvt. Ltd. Date Published : 07/10/2013
N-608, MIDC, Kupwad , Sangli, M.S., INDIA
11 Konduskar Laboratories Pvt Ltd Date Published : 07/10/2013
T-47 Kagel Hatkanangale Five Star, MIDC , Talandage (Village), Tal: Kagal, , Maharashtra State, INDIA 12 Micro Labs Limited Date Published : 08/21/2013
Plot No. 113-116 4th Phase KIADB , Bommasandra Industrial Area,Anekal Taluk , Bangalore, INDIA 13 Nivedita Chemicals P lTd Date Published : 11/23/2011
A14 MIDC Andheri East , Mumbai, IN-MH INDIA
14 Nivedita Chemicals Pvt. Ltd. Date Published : 11/23/2011 A-14 M.I.D.C. Andheri (East) , Maharashtra, MS INDIA 15 Promed Exports Private Limited Date Published : 06/20/2013
16 RPG Life Sciences Limited Date Published : 06/11/2013 3102/A G.I.D.C. Estate , 393002 , Ankleshwar, Gujarat INDIA 17 RPG Life Sciences Limited Date Published : 06/10/2013
25, M.I.D.C. Land, Thane-Belapur Road , Thane, Maharashtra INDIA 18 Ranbaxy Laboratories Limited Date Published : 09/13/2013
Phase III Industrial Area SAS Nagar , Mohali, Punjab, INDIA 19 Ranbaxy Laboratories, Limited Date Published : 09/10/2009
Paonta Sahib , Himachal Pradesh , Simour District, INDIA 20 Ranbaxy Laboratories, Ltd. Date Published : 09/13/2013
SEZ Unit 1, Plot No. A-41 , Industrial Area Phase VIII, SAS Nagar , Mohali, Punjab, INDIA 21 Ranbaxy Laboratories, Ltd. Date Published : 09/10/2009
Industrial Area No. 3 , Madhya Pradesh , Dewas, Mp INDIA 22 Smruthi Organics Limited Date Published : 06/03/2013
Unit Ii, Plot No. A-27, Midc, , Chincholi Village, Taluka Mohol , Solapur District, Maharashtra State, INDIA 23 Stericon Pharma Pvt. Ltd.Date Published : 01/13/2011
No. 9, Sub Layout Of Plot 9 , 1st Phase Bommasandra Ind. Area , Bangalore, Karnataka, INDIA 24 Unique Chemicals Date Published : 06/28/2013
Plot P-10, Shiv Mahape Gansoli , Thane Belapur Road, Maharashtra State , Navi Mumbai, INDIA 25 Vignesh Life Science Pvt LtdDate Published : 06/28/2013
202 Sarada Residency , H - 26 , Madhura Nagar Ameerpet , Hyderabad, Tamil Nadu INDIA 26 Vignesh Life Sciences Pvt., Ltd.Date Published : 06/28/2013
93 & 94 P Mundargi Industrial Estate , Bellary Karnataka, INDIA 27 Wintac Limited Date Published : 03/27/2012
163 Reservior Str , Bangalore, INDIA
28 Wintac Limited Date Published : 03/27/2012
54/1, Boodihal Village, Nelamangala , Taluk , Bangalore, INDIA 28 Wockhardt LimitedDate Published : 05/22/2013
Biotech Park, Plot H-14/2 , M.I.D.C. Area Waluj , Aurangabad, Maharashtra INDIA 29 Yag Mag Labs Private Limited Date Published : 09/13/2011
