BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU ( DEC 2017 PENDING ) Date of Receipt

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1 BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU ( DEC 2017 PENDING ) S. No. Name of the File (available with M/s. Apollo Hospital, Madurai 2. M/s. Govt. Head Quarters Hospital, Periyakulam 3. M/s. Govt. Hospital, Tindivanam 4. M/s. I.S.O. & Govt. Kasturba Gandhi Hospital for Women and Children and General Hospital, Chennai 5. M/s IRT Perundurai Medical College, Perundurai /06/2017 Renewal of license for the period 2018 to 2022 & Grant of components /09/ Renewal of license for the period from to period (Validity ). Bank license (Valid up to ) Bank license for the Joint inspection is proposed in 2018 since licence valid up to Page 1 of 17

2 6. Sudiksha Prabhu Hospital Blood bank &research Centre 7. M/s. Govt. Head Quarters Hospital, Kanchipuram 8. M/s. Steel Authority of India Limited 9. M/s. Mahatma Gandhi Memorial Govt. Hospital, Tiruchirapalli 10. M/s. The Tamilnadu Dr. M.G.R. Medical University 1 M/s. Neyveli Lignite Corporation India Limited 12. Hindu Mission hospital, Tambaram 13. Karur Blood bank /10/ /11/2017 bank bank Under Scrutiny Page 2 of 17

3 14. M/s. Cancer Institute, Chennai /11/ M/s. Govt Hospital, Gudiyatham M/s. Sree Mookambika Institute of Medical Sciences, Kulasekaram, Kanyakumari Dt 17. M/s. Government Head Quarters Hospital, Virudhunagar 18. M/s. Govt. RSRM-Lyingin- Hospital Royapuram, Chennai /12/ /11/2017 period period period from to bank to bank month of January month of May 2018 since the valid upto 15/04/ month of January M/s. Chengalpattu Medical College Hospital,Chengalpattu 20. Govt. Hospital, Virudhachalam, Cuddalore 2 Vivekanandha Medical care Hospital, Thiruchengodu 22. Life line Blood bank &Research centre, Tirunchivilli /11/ /11/ /11/ /12/2017 bank bank bank bank month of January 2018 month of January 2018 month of January 2018 month of January 2018 Page 3 of 17

4 23. Government Hospital, Pattukkottai /11/ Vivek Blood Bank & Regional Blood Transfusion Centre 25. Indian Voluntary Blood bank, Chennai 26. Govt. Hospital, Attur /12/ /12/ /12/2017 bank bank grant of Blood bank Verification of compliance. month of January 2018 BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA (available with M/s. Government Medical college, Kozhikode 2. M/s Little lourds Mission Hospital, Kottayam 3. District Hospital, Palakkad 4. M/s. Little Flower Hospital & Research /08/ period period period Bank license for the Joint inspection is proposed in 2018 since license valid up to in Since license valid up to in Since in Page 4 of 17

5 Centre, Angamaly period in Bank license for the period up to M/s. Mundakayam Medical Trust Hospital, Idukki 6. M/s. Nirmala Hospital, Calicut M/s. Sacred Heart General Hospital, Cherthala, Alappuzha Bank license Bank license in in 8. M/s Mother Hospital, Thrissur 9. M/s Caritas Hospital, Kottayam. 10. M/s. Pushpagiri Medical College Hospital, Tiruvalla 1 M/s. Lourdes Society for Health Care and Research, Ernakulam Bank license Bank license in in in in Page 5 of 17

6 12. M/s. Morning Star Medical Centre, Idukki 13. M/s. P.V.S. Hospital (P) Ltd, Calicut 14. M/s. Government Medical College, Thiruvananthapuram 15. M/s, Holy Ghost Mission Hospital, Kottayam 16. M/s. Immaculate Heart of Mary Hospital, Kottayam 17. M/s. Bishop Benziger Hospital, Kollam 18. M/s. Amala Cancer Hospital and Research Centre, Thrissur M/s. San Joe Hospital Perumabavoor in in in in in in in in Page 6 of 17

7 20. M/s. Mar Baselios Medical mission Association, Kothamangalam 2 M/s. Holy Cross Hospital, Pathanamthitta 22. DM Wayanad Institute of Medical sciences, Wayanad 23. M/s. Holy Cross Hospital, Adoor 24. M/s. District Hospital, Tirur 25. M/s.PVS Memorial Hospital, Kochi 26. M/s. The Malankara Orthodox Syrian Church Medical Hospital, Thrissur 27. M/s. The Malankara Orthodox Syrian Church Medical College Hospital, Ernakulam period period period Bank licence period to period to Compliance verification in in in the month of April up to 20/03/2018 in in 2018 in in in Page 7 of 17

8 28. M/s. SK Hospital, Trivandrum 29. Alphonsa Hospital, Idukki Dist, Kerala Medical Trust Hospital Blood Bank, M.G Road, cochin, Ernakulam- Dist. Kerala /12/ Maria Theresa Hospital, Thrissur, Kerla /11/ St.John s Hospital, Idukki, Kerala /11/ District Hospital, Waynad /12/ St. Thomas Hospital, Changanacherry, Kottayam 35. S.K.Hospital, Thiruvanthapuarm /12/ /11/17 grant of licence bank bank bank bank bank bank grant of for operation of Blood bank in in in in in in in Joint inspection proposed in BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY (available with Page 8 of 17

9 Indira Gandhi Hospital, Puducherry 2. M/s. Aarupadai Veedu Medical College, Puducherry 3. M/s. Padmavati's Hospital Limited 4. A.G. Padamavathi s Hospital Compliance verification Compliance verification /11/2017 Renewal of Blood bank /12/2017 Renewal of Blood bank in in in Under Scrutiny INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU M/s. Strides Shasun Limited, Cuddlore Kausikh (P) Ltd Therapeutics Orchid Healthcare, B- 77 SIDCO, AlathurKancheepuram (available with Renewal and Issuance of Issuance of /12/2017 Renewal of in in in Page 9 of 17

10 Madras Pharmaceuticals, Chennai Softgel Healthcare Pvt Ltd Panvo organics Ltd, Gummidipodhi /12/2017 Renewal of /12/2017 Renewal Of /12/2017 Renewal of DFF Pharma, Cuddlore /12/2017 Renewal of Orchid Pharma A 10, A11, SIDDCO Industrial estate, Alathur Caplin Point laboratories, Thriurveylur Malladi Drugs and Pharmaceutical ltd, chranipetta /11/2017 Renewal of /12/17 Renewal of /11/2017 Renewal of in in in in in in in INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA (available with Page 10 of 17

11 2. 3. M/s Nitta Gelatin India Limited, Cochin M/s HLL Lifecare Ltd., Trivandrum M/s. Megasys Biotek Pvt Ltd., Thrissur Revalidation Revalidation Revalidation of of of in in in INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY M/s. Alianz Bio Sciences Pvt. Ltd, Puducherry (available with Revalidation of Joint Inspection is proposed in the month of January CLINICAL TRAIL INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMILNADU (available with Fronterior Life line Chennai /11/2017 Approval of Clinical trial site Joint Inspection is proposed in the month of January Page 11 of 17

12 MEDICAL DEVICES INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA S.No 2. Name of the File M/s. TTK Healthcare Heart valve Division, Trivandrum M/s. Terumopenpol, Trivandrum (available with /11/ Renewal of license Joint Inspection is proposed in the month of January 2018 since license valid up to December Renewal of license Joint Inspection proposed in since license valid. VACCINES INSPECTIONS PROPOSED BY THIS OFFIC FOR THE STATE OF TAMIL NADU S.No Name of the File M/s. Institute of Veterinary Preventive Medicine, Ranipet (available with Directorate letter no 28D/Vet.Vac/11/IVPM/1 7-BD dt Renewal of manufacturing licence Joint Inspection is proposed in the month of January BA/BE INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU Page 12 of 17

13 S. No Name of the File M/s. Glocare Labs Pvt. Ltd, Chennai M/s. Quest Life Sciences (P) Ltd, Chennai M/s. Scitus Pharma Services Private Limited M/s. Ecron Acunova Limited (available with /08/ /05/ /10/ Grant of Approval Renewal of Approval Grant of Approval Grant of Approval Awaiting letter from O/o. DCG(I), New Delhi Awaiting letter from DCG(I) Requested by the firm for postponement. LVP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU M/s. Global Pharmatech, Hosur (available with Renewal of licence in the month of December LVP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA S. No Name of the File (available Page 13 of 17

14 M/s. Terumo Penpol, Trivandrum with Renewal of licence in MANUFACTURING LICENSE INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMILNADU Sri Home Consumbles Private Ltd, Thirumudivakkam, Chennai M/s. ProVentus Life Sciences Pvt. Ltd., M/s. Sivam Remedies Pvt. Ltd, Chennai Wellous Pharma private ltd, Villupuram (available with /11/2017 Grant of approval for for additional products /11/2017 Grant of approval for for additional products Grant of approval for Manufacturing 08/11/2017 Grant of approval for Manufacturing Reason & Remarks Page 14 of 17

15 5. Universal Pharmaceuticals Ltd, Methupalayam /11/2017 Grant of approval for Manufacturing MANUFACTURING LICENSE INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY Swati spentose Pvt Ltd, Manfactured at M/s. Sterile gene Life sciences (P) Ltd Ferring Pharmaceuticals, Manufactured at M/s. Sterile gene Life sciences (P) Ltd Cipla Ltd Manufactured at M/s. Sterile gene Life (available with /12/2017 Grant of approval for on Loan basis /11/2017 Grant of approval for on Loan basis /11/2017 Grant of approval for on Loan basis Reason & Remarks Page 15 of 17

16 sciences (P) Ltd Macromed Pharmaceuticals (P) Ltd., Villinur Helix pharma, puducherry Rajesh Health care products, Kanniyakoil Universal Pharmaceutical, Puducherry /12/2017 Grant of approval for for additional products /12/2017 Grant of approval for for additional products /12/2017 Grant of approval for for cosmetic products /12/2017 For approval of COSMETICS INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMILNADU M/s. Mowlee Soap Industries M/s. Golecha Naturals Pvt Ltd, Krsinagiri Dist Herboflora Biotech, Coimbature (available with /11/2017 Grant of for manufacture and sale of cosmetics /12/2017 Grant of approval for for cosmetic products 05/12/2017 Grant of for manufacture and sale of cosmetics Reason & Remarks Under Scrutiny Under Scrutiny Page 16 of 17

17 LABORATORY INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMILNADU 1 2. M/s. Welous Pharma Private Limited, Villipuram Neoscience Labs Private Ltd., sithalapakkam, Chennai (available with /12/2017 Page 17 of 17

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