The document lists warning letters issued by the FDA to various companies in India between May 2022 and March 2017. It includes the company name, product type (drugs, devices, food/cosmetics), action taken date, type of action (warning letter), and case ID for each letter. A total of 86 warning letters are listed to companies in India for drugs, devices, and food/cosmetic products over this time period.
The document lists warning letters issued by the FDA to various companies in India between May 2022 and March 2017. It includes the company name, product type (drugs, devices, food/cosmetics), action taken date, type of action (warning letter), and case ID for each letter. A total of 86 warning letters are listed to companies in India for drugs, devices, and food/cosmetic products over this time period.
The document lists warning letters issued by the FDA to various companies in India between May 2022 and March 2017. It includes the company name, product type (drugs, devices, food/cosmetics), action taken date, type of action (warning letter), and case ID for each letter. A total of 86 warning letters are listed to companies in India for drugs, devices, and food/cosmetic products over this time period.
FEI Number Firm Name Product Type Action Type Injunction Area Date ID 3010409208 Arya Vaidya Sala Kottakkal India Drugs 05/19/2022 Warning Letter 628168 3005564386 Indiana Chem-Port India Drugs 01/31/2022 Warning Letter 618173 3004021253 Aurobindo Pharma Limited (Unit I) India Drugs 01/13/2022 Warning Letter 618091 3015394334 Biotek India India Drugs 05/13/2021 Warning Letter 613295 3009876430 Shilpa Medicare Limited India Drugs 10/09/2020 Warning Letter 607877 3007187282 Panacea Biotec Pharma Limited India Drugs 09/25/2020 Warning Letter 607837 3010910756 Mayon'S Pharmaceuticals Pvt Ltd India Drugs 09/04/2020 Warning Letter 607388 3003227156 Mylan Laboratories Ltd. (Unit 7) India Drugs 08/20/2020 Warning Letter 607508 3003821988 Somerset Therapeutics Limited India Drugs 08/13/2020 Warning Letter 606700 3016998483 Kegan Wellness India Drugs 07/13/2020 Warning Letter 608737 3015658387 Vega Life Sciences India Drugs 06/17/2020 Warning Letter 604469 3003348363 Angiplast Private Limited India Devices 05/14/2020 Warning Letter 607616 3003759643 Indus Medicare Limited India Devices 05/04/2020 Warning Letter 606159 3011108348 Dr. Dhole's Sushanti Homeopathy Clinic India Drugs 05/04/2020 Warning Letter 607348 3009167769 Kumar Organic Products Limited India Drugs 04/23/2020 Warning Letter 598683 3016609914 Emedkit.com India Drugs 04/23/2020 Warning Letter 606138 3002808145 Shriram Institute for Industrial Research India Drugs 04/15/2020 Warning Letter 597629 3016551424 Alpha Arogya India Pvt. Ltd. (The GBS Group) India Drugs 04/13/2020 Warning Letter 606253 3016601904 Homeomart Indibuy India Drugs 04/01/2020 Warning Letter 605888 3008316085 Pfizer Healthcare India Private Limited India Drugs 03/24/2020 Warning Letter 594972 3005339091 Windlas Healthcare Private Limited India Drugs 03/10/2020 Warning Letter 595494 3014466792 ESSND GLOBAL India Drugs 02/14/2020 Warning Letter 595850 3009223273 JHS SVENDGAARD LABORATORIES LTD India Drugs 02/13/2020 Warning Letter 593473 3004081307 Cipla Limited India Drugs 02/12/2020 Warning Letter 597511 3008311641 GPT Pharmaceuticals Private Ltd India Drugs 12/17/2019 Warning Letter 590938 3002785310 Mylan Laboratories Limited (Unit 8) India Drugs 11/05/2019 Warning Letter 589297 3002984011 ZYDUS LIFESCIENCES LIMITED India Drugs 10/29/2019 Warning Letter 584856 3005029956 Torrent Pharmaceuticals Limited India Drugs 10/08/2019 Warning Letter 585255 3010206088 K-Pra Foods Private Limited India Food/Cosmetics 10/08/2019 Warning Letter 592680 3005757050 Glenmark Pharmaceuticals Limited India Drugs 10/03/2019 Warning Letter 582701 3002807511 Lupin Limited India Drugs 09/10/2019 Warning Letter 572345 3010203525 Shree Datt Aquaculture Farms India Food/Cosmetics 08/22/2019 Warning Letter 588773 3012390454 Lantech Pharmaceuticals Limited India Drugs 08/08/2019 Warning Letter 580027 3005151215 Emcure Pharmaceuticals Limited India Drugs 08/02/2019 Warning Letter 576961 3006254924 CTX Lifesciences Private Ltd. India Drugs 07/12/2019 Warning Letter 577416 3006644152 Indoco Remedies Limited (Plant I) India Drugs 07/09/2019 Warning Letter 575313 3012448465 Strides Pharma Science Limited India Drugs 07/01/2019 Warning Letter 576722 3004611182 Aurobindo Pharma Limited India Drugs 06/20/2019 Warning Letter 577033 3005269310 Rxhomeo Private Limited India Drugs 06/13/2019 Warning Letter 575889 3009729392 Glint Cosmetics Pvt Ltd India Drugs 05/31/2019 Warning Letter 573468 3008342939 Centurion Laboratories Private Limited India Drugs 05/04/2019 Warning Letter 571255 3006217304 Contacare Ophthalmics & Diagnostics India Drugs 04/23/2019 Warning Letter 570360 3010212308 B. JAIN PHARMACEUTICALS PRIVATE LIMITED India Drugs 03/21/2019 Warning Letter 567957 3006895982 Jubilant Generics Limited India Drugs 03/06/2019 Warning Letter 569799 3008386908 Pfizer Healthcare India Private Ltd. India Drugs 03/04/2019 Warning Letter 557890 3007450508 Anicare Pharmaceuticals Pvt Ltd. India Drugs 02/28/2019 Warning Letter 569251 3009838739 Emmbrose Overseas India Food/Cosmetics 02/05/2019 Warning Letter 565631 3008003126 Www.ayurvediccure.com India Food/Cosmetics 02/05/2019 Warning Letter 565631 3003090962 Vipor Chemicals Private Ltd. India Drugs 01/29/2019 Warning Letter 555392 3003658163 Skylark CMC Private Limited India Drugs 12/03/2018 Warning Letter 567229 3004974700 Wilson Medicine Company India Drugs 09/11/2018 Warning Letter 557206 3006076314 Apotex Research Private Limited India Drugs 08/09/2018 Warning Letter 547439 3005543404 P Banerji Mihijam Pharmaceuticals India Drugs 08/07/2018 Warning Letter 547958 3011783104 JT Cosmetics & Chemicals Pvt Ltd. India Drugs 07/27/2018 Warning Letter 554478 3004610460 Baxter Pharmaceuticals India Pvt Ltd India Drugs 07/05/2018 Warning Letter 543187 3011543431 Reine Lifescience India Drugs 05/09/2018 Warning Letter 548293 3009336980 Goran Pharma Pvt Ltd India Drugs 04/24/2018 Warning Letter 545331 3003677831 Keshava Organics Private Ltd. India Drugs 03/15/2018 Warning Letter 540146 3005115135 Malladi Drugs & Pharmaceuticals Ltd. India Drugs 03/09/2018 Warning Letter 541915 3005216842 Alchymars ICM SM Private Limited India Drugs 02/16/2018 Warning Letter 542879 3007931994 Fleming Laboratories Limited India Drugs 02/14/2018 Warning Letter 537647 3006210232 Fresenius Kabi Oncology Limited (Baddi) India Drugs 12/18/2017 Warning Letter 526863 3003519498 Fresenius Kabi Oncology Ltd India Drugs 12/04/2017 Warning Letter 538641 3004819820 Lupin Limited India Drugs 11/06/2017 Warning Letter 532465 3007549629 Lupin Limited India Drugs 11/06/2017 Warning Letter 535014 3006513362 GPC Medical Ltd. India Devices 10/20/2017 Warning Letter 536145 3006370331 Kim Chemicals Private Ltd. India Drugs 10/16/2017 Warning Letter 535531 3007474872 Vital Laboratories Pvt Ltd Plant II India Drugs 10/11/2017 Warning Letter 527253 3008307735 Hetero Labs Limited (Unit V) India Drugs 08/15/2017 Warning Letter 520359 3010943365 Haldiram Snacks Pvt. Ltd. India Food/Cosmetics 07/06/2017 Warning Letter 525906 3003978209 Vista Pharmaceuticals Limited India Drugs 07/05/2017 Warning Letter 515652 3004982352 Vikshara Trading & Investment Ltd. India Drugs 04/28/2017 Warning Letter 516856 3003916387 Sal Pharma India Drugs 04/20/2017 Warning Letter 516205 3004149463 Divi's Laboratories Ltd. (Unit II) India Drugs 04/13/2017 Warning Letter 518434 3005124189 Indoco Remedies Limited India Drugs 03/31/2017 Warning Letter 514601 3005587313 Mylan Laboratories Limited India Drugs 03/31/2017 Warning Letter 517906 3004086192 USV Limited India Drugs 03/10/2017 Warning Letter 510159 3004058356 Badrivishal Chemicals & Pharmaceuticals India Drugs 03/06/2017 Warning Letter 511820 3006688078 Megafine Pharma (P) Limited India Drugs 02/24/2017 Warning Letter 510862 3004483648 Resonance Laboratories Private Limited India Drugs 02/03/2017 Warning Letter 511907 3006254924 CTX Lifesciences Private Ltd. India Drugs 01/18/2017 Warning Letter 496393 3002808500 Wockhardt, Ltd. India Drugs 12/23/2016 Warning Letter 495920 3005048741 Srikem Laboratories Pvt. Ltd. India Drugs 11/10/2016 Warning Letter 496015 3010532174 Pan Drugs Limited India Drugs 08/25/2016 Warning Letter 490052 3004414652 Unimark Remedies Limited India Drugs 08/12/2016 Warning Letter 483816 3008117347 Unimark Remedies Limited India Drugs 08/12/2016 Warning Letter 483816 3010005781 Keshodwala Foods (Unit 2) India Food/Cosmetics 07/07/2016 Warning Letter 497101 3007931994 Fleming Laboratories Limited India Drugs 06/21/2016 Warning Letter 438607 3012278106 Anil Gangwani India Drugs 06/02/2016 Warning Letter 495560 3005694111 Megafine Pharma (P) Limited India Drugs 05/19/2016 Warning Letter 479195 3002939122 Hindustan Syringes & Medical Devices Ltd. India Devices 05/13/2016 Warning Letter 494040 3007287078 Polydrug Laboratories Pvt. Ltd. India Drugs 04/14/2016 Warning Letter 477491 3005280525 Sri Krishna Pharmaceuticals Ltd. - Unit II India Drugs 04/01/2016 Warning Letter 472869 3005151215 Emcure Pharmaceuticals Limited India Drugs 03/03/2016 Warning Letter 455201 3002807297 Ipca Laboratories Limited India Drugs 01/29/2016 Warning Letter 442963 3005977675 Ipca Laboratories Limited India Drugs 01/29/2016 Warning Letter 442963 3007574780 Ipca Laboratories LTd India Drugs 01/29/2016 Warning Letter 442963 3002984011 ZYDUS LIFESCIENCES LIMITED India Drugs 12/23/2015 Warning Letter 471062 3006595385 Zydus Lifesciences Limited India Drugs 12/23/2015 Warning Letter 471062 3002809586 Sun Pharmaceutical Industries Ltd. India Drugs 12/17/2015 Warning Letter 458804 3013295623 IMPROVA HERBAL PRODUCTS India Food/Cosmetics 12/15/2015 Warning Letter 484327 3005447965 Dr. Reddy's Laboratories Limited India Drugs 11/05/2015 Warning Letter 481160 3002949085 Dr. Reddy's Laboratories Limited CTO VI India Drugs 11/05/2015 Warning Letter 481160 3006549835 Dr. Reddy's Laboratories Ltd. India Drugs 11/05/2015 Warning Letter 481160 3003737804 Sandoz Private Limited India Drugs 11/02/2015 Warning Letter 445532 3004944629 Sandoz Private Limited India Drugs 11/02/2015 Warning Letter 445532 3005202703 Unimark Remedies Ltd. India Drugs 09/29/2015 Warning Letter 429340 3011776846 Rudra Ventures Pvt. Ltd. India Tobacco 09/03/2015 Warning Letter 478224 3003263118 Pan Drugs Ltd. India Drugs 09/02/2015 Warning Letter 446630 3007512701 Mylan Laboratories Limited India Drugs 08/07/2015 Warning Letter 464863 3007648351 Mylan Laboratories Limited, Speciality Formulation Facility India Drugs 08/07/2015 Warning Letter 464863 3003813519 Steriscience Specialties Private Limited India Drugs 08/07/2015 Warning Letter 464863 3004275148 Keshodwala Foods (Unit 1) India Food/Cosmetics 08/03/2015 Warning Letter 472941 3004544153 Sipra Labs Limited India Drugs 07/23/2015 Warning Letter 431553 3003802404 Mahendra Chemicals India Drugs 07/13/2015 Warning Letter 438517 3005925733 Sharon Bio-Medicine Limited India Drugs 06/22/2015 Warning Letter 471663 3003978209 Vista Pharmaceuticals Limited India Drugs 06/22/2015 Warning Letter 471701 3006076314 Apotex Research Private Limited India Drugs 01/30/2015 Warning Letter 437669 3005210225 Micro Labs Limited India Drugs 01/09/2015 Warning Letter 437438 3005483737 Degania Medical Devices Pvt. Ltd. India Devices 12/23/2014 Warning Letter 443502 3007788637 K.I.Z. FOODS LIMITED India Food/Cosmetics 11/12/2014 Warning Letter 441450 3004161432 Sharp Global Limited India Drugs 10/15/2014 Warning Letter 428474 3002806711 Cadila Pharmaceuticals Limited India Drugs 10/15/2014 Warning Letter 429369 1000591683 Grandmas Food Products India Food/Cosmetics 09/24/2014 Warning Letter 437401 3006257565 Amanta Healthcare Ltd. India Drugs 08/26/2014 Warning Letter 438593 3006257565 Amanta Healthcare Ltd. India Drugs 07/08/2014 Warning Letter 418268 3005466325 Apotex Pharmachem India Pvt Ltd. India Drugs 06/16/2014 Warning Letter 423752 1000372855 Accelerated Freeze Drying Co. Ltd. India Food/Cosmetics 06/02/2014 Warning Letter 428681 3005409363 Sun Pharmaceutical Industries Limited - Karkhadi India Drugs 05/09/2014 Warning Letter 418746 3005527296 Labotech Microscopes India Private Limited India Devices 04/21/2014 Warning Letter 419092 3004896392 Smruthi Organics Limited India Drugs 03/06/2014 Warning Letter 416931 3005056599 Britto Sea Foods Exports Pvt. Ltd. India Food/Cosmetics 03/06/2014 Warning Letter 420326 3003297374 Canton Laboratories Private Ltd. India Drugs 02/27/2014 Warning Letter 413940 3003255171 Usv Limited India Drugs 02/06/2014 Warning Letter 413332 3004257616 Gadre Marine Export Pvt. Ltd. India Food/Cosmetics 01/16/2014 Warning Letter 418122 2000017604 Parayil Food Products Pvt. Ltd. India Food/Cosmetics 12/13/2013 Warning Letter 414411 3002808503 Wockhardt Limited India Drugs 11/25/2013 Warning Letter 412858 3002731916 Shoney Scientific India India Devices 11/20/2013 Warning Letter 411720 3007648351 Mylan Laboratories Limited, Speciality Formulation Facility India Drugs 09/09/2013 Warning Letter 409756 3008250236 Sentiss Pharma Pvt. Ltd. India Drugs 08/12/2013 Warning Letter 398060 3006418686 Aarti Drugs Limited India Drugs 08/02/2013 Warning Letter 397189 3009688205 Aarti Drugs Ltd India Drugs 08/02/2013 Warning Letter 397189 3001329340 Valens Molecules Private Limited India Drugs 08/02/2013 Warning Letter 398629 3010239376 www.desismokes.com India Tobacco 07/26/2013 Warning Letter 406880 3005289335 Wockhardt Limited India Drugs 07/18/2013 Warning Letter 396819 3007972864 AMRUTAM LIFE CARE PRIVATE LIMITED India Drugs 07/15/2013 Warning Letter 395196 3003519498 Fresenius Kabi Oncology Ltd India Drugs 07/01/2013 Warning Letter 393890 3008386908 Pfizer Healthcare India Private Ltd. India Drugs 05/28/2013 Warning Letter 382438 3003269328 RPG Life Sciences Limited India Drugs 05/28/2013 Warning Letter 392574 3008314161 RPG Life Sciences Limited India Drugs 05/28/2013 Warning Letter 392574 3010004588 Discount Online Pharmacy India Drugs 02/12/2013 Warning Letter 392439 3009966662 buy-pharma.com India Drugs 02/04/2013 Warning Letter 391562 3003916387 Sal Pharma India Drugs 05/30/2012 Warning Letter 301698 3003263118 Pan Drugs Ltd. India Drugs 02/28/2012 Warning Letter 284758 3003821988 Somerset Therapeutics Limited India Drugs 02/23/2012 Warning Letter 241074 3002807977 Sun Pharmaceutical Industries (prev. Ranbaxy) India Drugs 01/25/2012 Injunction 234 3002807978 Sun Pharmaceutical Industries (prev. Ranbaxy) India Drugs 01/25/2012 Injunction 234 3003747592 Xylo Chem Industries India Drugs 11/16/2011 Warning Letter 218896 3004896339 Yag Mag Labs Private Limited India Drugs 09/12/2011 Warning Letter 213033 3002984011 ZYDUS LIFESCIENCES LIMITED India Drugs 06/21/2011 Warning Letter 192132 3004021263 Aurobindo Pharma Limited, Unit VI India Drugs 05/20/2011 Warning Letter 180094 3002731916 Shoney Scientific India India Devices 01/20/2011 Warning Letter 146752 3008494993 Synbiotics Limited India Drugs 12/16/2010 Warning Letter 136712 3004610460 Baxter Pharmaceuticals India Pvt Ltd India Drugs 11/01/2010 Warning Letter 134950 3008299032 Choksi Laboratory India Drugs 09/30/2010 Warning Letter 135190 3004944585 HEALTHIUM MEDTECH PRIVATE LIMITED India Devices 09/03/2010 Warning Letter 123328 3004983128 Stericon Pharma Pvt. Ltd. India Drugs 08/24/2010 Warning Letter 122649 3008314444 Saurabh Overseas India Food/Cosmetics 06/02/2010 Warning Letter 107525 3008186667 Shreeji Homeo Clinic India Drugs 04/13/2010 Warning Letter 95710 3008003126 Www.ayurvediccure.com India Food/Cosmetics 01/26/2010 Warning Letter 89004 3007950257 Mendez, Dr Antonio India Drugs 11/17/2009 Warning Letter 84158 3002807511 Lupin Limited India Drugs 05/07/2009 Warning Letter 55122