BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF TAMIL NADU

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1 BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE S. No. Name of the File 1 M/s. Life Cell International Pvt. Ltd., /11/ M/s. Annai Terasa Blood Bank & Apheresis Centre, 3. M/s. Dhanalakshmi Srinivasan Medical Collge, Perumbalur 4. M/s. Maruthi Blood Bank, Salem 5. M/s. Palaniandi Mudaliar Memorial Hospital, Salem 6. M/s. KSM Blood Bank, Salem 7. M/s. The Salvation Army Catherine Booth Hospital, Nagercoil 8. M/s. Galaxy Hospital, Tirunelveli /11/ M/s. St. Joseph Hospital, Dindigul 10. M/s. Thoothukudi Medical College Hospital, Thoothukudi 1 M/s. Sri Ramachandra Medical College and Research Centre, Awaiting for instruction from the O/o. Drugs Controller General (India) /04/2015 Blood Bank requested additional time for joint inspection /10/2015 the month of April Since licence valid up to /06/2015 Joint inspection proposed on /01/2016 Joint inspection proposed on /03/2015 Joint inspection proposed on Blood bank has submitted rectification report on for renewal of /11/2015 licence. Awaiting letter from SLA for verification of compliance of previous inspection /12/ /12/ /12/ M/s. Southern Railway Hospital Blood Bank, /12/ M/s. Jeyashekaran Hospital & Nursing, Nagercoil /01/2016 the month of February on the month of February the month of April Since the licence valid up to March 2016 the month of February M/s. Govt. Hospital, /12/2015 Joint inspection proposed

2 Thiruvarur on M/s. Govt. Hospital, Padmanabapuram /01/ M/s. Govt. Hospital Blood Bank, Erode /12/2015 the month of April Since the licence valid up to March 2016 the month of February BLOOD BANK FILES PENDING FOR WANT OF BLOOD BANK REPLY (available with M/s. Sivanthi Blood Bank, Nagercoil /11/2014 M/s. Thangam Blood Bank, Nagercoil M/s. Kongu Blood Bank & Components Centre, Erode M/s. Swaasam Blood Bank, Coimbatore M/s. Lords Blood Bank, Nagercoil Purpose Grant of Blood Bank licence for processing of Blood Components Renewal of licence for the period from /11/ to for Whole Human Blood /07/2015 Grant of licence due to change in constitution /06/2015 Renewal of licence for the period from to & Grant of Components /09/2015 Renewal of licence for the period from to /11/2015 Renewal of licence 6. M/s. Indian Blood Bank, Dindigul 7. M/s. Sriram Blood /11/2015 Grant of licence due to Bank Trust, Erode change in constitution M/s. Madras Egmore /12/2015 Renewal of licence 8. Lions Blood Bank & Research Foundation, M/s. Pollachi Blood /07/2015 Grant of Blood Bank 9. Bank Service, licence due to Change Pollachi of Premises 10. M/s. Bethel Blood /12/2015 Renewal of licence Reason & Remarks Query raised for submission of SBTC NOC. 2

3 Bank Services Trust, Tirunelveli Town M/s. V. Dhanasamy - Parimaladevi Medical Trust Blood Bank, Vidhunagar M/s. Apollo Speciality Hospital, M/s. Doctors Blood Bank & Research Centre, Trichy M/s. Apollo Hospitals Enterprises Ltd, 37 10/04/2015 Grant of Blood Bank licence for processing of Blood Components 74 15/04/2015 Grant of Apheresis /10/2015 Grant of Blood Bank licence for processing of Apheresis /10/2015 Renewal of licence Query raised for submission of documents & SBTC M/s. Government Dist. HQ Hospital Blood Bank, Nagapattinam M/s. K.M.R. Blood Bank, Thanjavur /12/2015 Endorsement of additional blood components /12/2015 Renewal of licence BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA M/s. Jubilee Mission Hospital, Thrissur 2. M/s. Medical College Hospital, Thrissur 3. M/s. Medical Trust Hospital, Cochin 4. M/s. Taluk Headquarters Hospital, Chirayinkeezhu 5. M/s. Muthoot Medical Centre, Pathanamthitta 6. M/s. Aster Medcity, Kochi 7. M/s. St. James Hospital, Chalakudy /11/ /12/ /12/ /01/ /12/ /12/ /12/2015 3

4 2. COPP INSPECTIONS PROPOSED BY THIS OFFICE M/s. Apex Laboratories Pvt Ltd, Alathur, Kancheepuram Dist /01/2015 M/s. Vivimed labs, Alathur Pvt Ltd, Alathur /01/2016 The manufacturer requested for postponement of joint inspection due to renovation work M/s. Vinkem Labs Ltd, Kakkalur /12/2015 M/s. Malladi Drugs & Pharmaceuticals Pvt Ltd, Ranipet M/s. Hospira Healthcare India Pvt Ltd, /11/ /02/2015 M/s. Wardex Pharmaceuticals Pvt Ltd, /12/2015 M/s. Orchid Healthcare, Irunkattukottai, Kancheepuram (Plot. B-5, B-6) /01/2016 M/s. B. Braun Medical India Pvt Ltd, Chengalpet /12/ This office received application on Query raised Reply received on Joint inspection proposed in the month of February the month of March COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY 2. M/s. Innvol Medical India Ltd, Kanchipuram /03/2014 M/s. Sara Pharmaceuticals, Nagercoil /12/2014 Application received on Query raised on , Awaiting reply Application received on Query raised on , Awaiting reply

5 M/s. Sterling Labs, Hosur Joint inspection postponed due /04/2015 to maintenance work in the premises M/s. Aurolab, Madurai /01/2016 submission, Awaiting reply M/s. Aurolab, Madurai /01/2016 submission, Awaiting reply M/s. Piramal Healthacare, /11/2015 submission, Awaiting reply M/s. Arvind Remedies, /12/2015 submission, Awaiting reply M/s. Global Calcium, Hosur (Unit III) /12/2015 M/s. Global Calcium, Hosur (Unit I) /12/2015 M/s. Alchymars, Alathur /01/2016 M/s. Global Pharma Healthcare, Alathur M/s. Mylan Laboratories, Hosur M/s. Global Pharmatech Pvt Ltd, Hosur /12/2015 M/s. Micro Labs Ltd, Hosur /01/ /01/ /12/2015 M/s. Strides Shasun Pvt Ltd, Cuddalore /12/2015 M/s. Orchid Healthcare, Alathur (Plot No. B-77), Kancheepuram Dt /01/2016 M/s. Franco Indian Remedies Pvt Ltd, /01/2016 M/s. Steadman Pharmaceuticals Pvt Ltd, Alathur /11/2015 Firm requested for postponement 5

6 19. M/s. Orchid Pharma Ltd, Alathur (Plot ) /01/2016 COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA M/s. Holden Medical Laboratories at M/s. Sance Laboratories Pvt ltd, Kottayam /10/2015 Application received on 06/10/2015. Query raised on 09/10/2015, Awaiting reply Reply from manufacturer received on 15/12/2015. COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF KERALA M/s. Labinduss Ltd, Palakkad /10/2014 Application received on Query raised on , Awaiting reply from the manufacturer. COPP INSPECTIONS PROPOSED BY THIS OFFICE FOR THE STATE OF PUDUCHERRY M/s. Micro Labs Ltd (Unit -III), Puducherry M/s. Goodman Pharmaceuticals, Puducherry M/s. Strides Shasun Pvt Ltd, Puducherry M/s. Restech Pharma, Puducherry /11/2015 Firm requested joint inspection in the month of March 2016 due to up gradation of facility /01/2016 Under Scrutiny /01/2016 State Drugs Inspector not ready for inspection /01/2016 6

7 COPP FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY- M/s. Safetab Life Science, Puduchery /03/2014 Application received on Query raised on , Awaiting reply from the manufacturer. MEDICAL DEVICE FILES PROPOSED BY THIS OFFICE M/s. Excel Optics Pvt., Ltd, (available with /10/2015 M/s. Eagle Osteon Technologies, /09/2015 M/s. AI-Optics Ltd, M/s. Synkromax Biotech Pvt Ltd, (Compliance Verification) M/s. Medevis Rubplast India Pvt Ltd, Coimbatore /01/ /01/ /05/2015 Joint inspection proposed in the month of February 2016 The firm requested sometime for joint inspection Under Scrutiny Joint inspection proposed on 03 rd & 04 th February 2016 Joint inspection proposed on 11 th & 12 th February 2016 MEDICAL DEVICE FILES PROPOSED BY THIS OFFICE FOR THE STATE OF KERALA M/s. HLL Lifecare Ltd, Thiruvananthapuram /07/2015 This office received application on 06/07/2015. Query raised on 07/07/2015. Reply received on 23/10/2015. Joint inspection proposed in the month of February

8 MEDICAL DEVICE FILES PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF KERALA M/s. Jayon Implants Pvt Ltd, Palakkad (Compliance verification /08/2015 Query raised, reply not received from the manufacturer VACCINE FILES PENDING FOR WANT OF MANUFACTURER REPLY M/s. Mediclone Biotech Pvt Ltd, (Renewal) (available with /02/2015 Query raised, reply not received from the manufacturer BA/BE INSPECTIONS PROPOSED BY THIS OFFICE M/s. Quest Life Sciences, /11/2015 Awaiting letter from DCG(I ), New Delhi for Joint inspection EU WRITTEN CONFIRMATION FILES PROPOSED BY THIS OFFICE M/s. Shasun Pharmaceuticals Ltd, Cuddalore /09/2015 This office received application on 29/09/2015. The firm requested for postponement due to heavy rain. The firm submitted another application for COPP on 22/12/2015. Query raised on 12/01/2016. Reply from manufacturer yet to be received. 8

9 2. M/s. Sun Pharma, /12/2015 the month of February M/s. Pharmazell India Pvt Ltd, /01/2015 the month of February 2016 EU WRITTEN CONFIRMATION PENDING FOR WANT OF MANUFACTURER REPLY M/s. Eucare Pharmaceuticals, /01/2016 Query raised. Reply yet to be received EU WRITTEN CONFIRMATION PENDING FOR WANT OF MANUFACTURER REPLY FOR THE STATE OF PUDUCHERRY M/s. Natural Capsules, Puducherry /09/2015 Application received on 21/09/2015. Query raised on 06/10/2015, Awaiting reply from the manufacturer. PENDING LIST OF NOC FOR DUAL USE FILES S. No. Name of the File (Available with NIL 9

10 PENDING LIST OF NOC FOR FORM-29 FILES S. No. Name of the File (Available with NIL PENDING LIST OF NOC FOR EXPORT-NOC FILES S. No. Name of the File (Available with NIL PENDING LIST OF NOC FOR TEST LICENCE (FORM - 11) FILES S. No. Name of the File (Available with NIL 10

/12/ /01/ /01/2016

/12/ /01/ /01/2016 BLOOD BANK INSPECTIONS PROPOSED BY THIS OFFICE S. No. Name of the File (available with 1 M/s. Life Cell International Pvt. Ltd., 127 2255 13/11/2014 M/s. Annai Terasa Blood Bank & Apheresis Centre, M/s.

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