Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs: Import Alert 66-40 Of US FDA

Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs Import Alert 66-40 Of US FDAThe United States Food and Drug Administration (U.S. FDA) has issued the import alert No. 66-40 that deals with Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug Good Manufacturing Practices (GMPs). This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.

For the alert, please see Import Alert 66-40- Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs (PDF).

As per U.S. FDA detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current GMPs. DWPE 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.

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 documentation.

Some of the Indian firms/companies listed under this alert are Amsal Chem Pvt. Ltd. A-1/401-402-403, GIDC , Ankleshwar, Gujarat, Apotex Pharmachem India Pvt Ltd. Plot No.: 1A, Bommasandra , Industrial Area, 4th Phase , Bangalore, Aurobindo Pharma Limited, Unit VI, Unit 6, Survey No. 329/39 & 329/47 , Chitkul Village, Patancheru Mandal , Hyderabad, Andhra Pradesh, Canton Laboratories Pvt. Ltd.110 A & B GIDC Industrial Estate , Makarpura , Baroda, Gujarat, Fleming Laboratories Limited, Plot No. 48, Temple Rock Enclave , Tarbund X Road , Secunderabad, Fleming Laboratories Ltd. Survey 270, Navabpet Village , Shivampet Mandal, Medak District, Andhra Pradesh, Global Calcium Private Limited,  No. 19 & 19B, Sipcot Industrial Complex , Krishnagiri District , Hosur, Tamil Nadu, Global Calcium Pvt, Box 3411 , Bangalore, Global Calcium Pvt Ltd, 711 Karomangala 111 Block, Global Calcium Pvt Ltd, No 1 2 Nd Floor 17th Main , Bangalore,Global Calcium Pvt. Limited, 125/126 Sipcot Industrial Complex , Hosur, Tamil Nadu, Kamud Drugs Pvt. Ltd. N-608, MIDC, Kupwad , Sangli, M.S., Konduskar Laboratories Pvt Ltd. T-47 Kagel Hatkanangale Five Star, MIDC , Talandage (Village), Tal: Kagal, , Maharashtra State, Marck Biosciences Ltd. Plot No. 876, N.H. – 8 , Vill: Hariyala, Tal: Matar , Kheda, Gujarat, Micro Labs Limited.  Plot No. 113-116 4th Phase KIADB , Bommasandra Industrial Area,Anekal Taluk , Bangalore, Nivedita Chemicals Pvt. Ltd. A14 MIDC Andheri East , Mumbai, Nivedita Chemicals Pvt. Ltd. A-14 M.I.D.C. Andheri (East) , Maharashtra, RPG Life Sciences Limited. 3102/A G.I.D.C. Estate , 393002 , Ankleshwar, Gujarat, RPG Life Sciences Limited. 25, M.I.D.C. Land, Thane-Belapur Road, Thane, Maharashtra, Ranbaxy Laboratories Limited. Phase III Industrial Area SAS Nagar , Mohali, Punjab, Ranbaxy Laboratories Ltd.- Sirmour Village & Post Office Ganguwala , Tehsil, Paonta Sahib , Simour District, Himachal Pradesh, Ranbaxy Laboratories, Ltd. SEZ Unit 1, Plot No. A-41, Industrial Area Phase VIII, SAS Nagar, Chandigarh, Ranbaxy Laboratories, Ltd. Industrial Area No. 3, Madhya Pradesh , Dewas, MP, Sentiss Pharma (frmly: Promed Exports), Village Khera Nihla, Tehsil Nalargarh , District Solan, , Himachal Pradesh, Smruthi Organics Limited. Plot No. A-27, MIDC, Chincholi , Solapur District, Maharashtra, Stericon Pharma Pvt. Ltd. No. 9, Sub Layout Of Plot 9 , 1st Phase Bommasandra Ind. Area , Bangalore, Karnataka, Sun Pharmaceutical Industries Limited – Karkhadi. Plot No. 817/A, Village – Karkhadi , Taluka – Padra District , Vadodara, Gujarat, Unique Chemicals. Plot P-10, Shiv Mahape Gansoli , Thane Belapur Road, Maharashtra State , Navi Mumbai, Vignesh Life Science Pvt Ltd. 202 Sarada Residency , H – 26 , Madhura Nagar Ameerpet , Hyderabad, Tamil Nadu, Vignesh Life Sciences Pvt., Ltd. 93 & 94 P Mundargi Industrial Estate , Bellary Karnataka, Wintac Limited. 54/1, Boodhihal Village, Nelamangala , Taluk , Bangalore Rural, Karnataka, Wintac Limited. 163 Reservior Str , Bangalore, Wockhardt Limited. L-1, MIDC Area, Jalgaon Road 43 , Chikalthana , Aurangabad, Maharashtra, Wockhardt Limited. Biotech Park, Plot H-14/2 , M.I.D.C. Area Waluj , Aurangabad, Maharashtra and Yag Mag Labs Private Limited. Survey No. 10, Gaddapotharam Village, , Jinnatam Mandel , Medak District, AP.

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