amanta - moph devices/medical devices... · amanta healthcare limited, kheda. urgent -field safety...
TRANSCRIPT
Amanta Registered & Corporate Office: Amanta Healthcare Ltd. (Formerly, Marek Biosciences Ltd.) 5th Floor, Heritage, Nr. Gujarat Vidhyapith, Ashram Road, Ahmedabad-380014, Gujarat. INDIA. Tel.: +91-79-30017500 Fax: +91-79-30017600 Ematl: [email protected] Website: www.amanta.co.in
GIN: U24139GJ1994PLC023944
Amanta Healthcare Limited, Kheda. URGENT - FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION
Notification and Modification to Labelling Page No. : 1 of 4
Date: 20/08/2015
Commercial Name of Affected Product Emergency Sterile Eye Wash (Sodium chloride 0.9% w/v Ph.Eur)
FSN Number FSN/NS/15/004
Date of Notification 201h , August 2015
Type of Action Notification and Modification to Labelling Contents
Details on Affected Device Sodium chloride 0.9% w/v Ph.Eur
To,
Medikit Limited,
Unit 1 Newporte Business Park Bishops Road,
Lincoln, Lincolnshire
LN24SY, UK
Description of Problem :
Name and Address of Manufacturer is not available on Label.
Impact on Patient Safety and Device Efficacy :
There is no impact on Quality, Safety and Efficacy of the Device.
All essential information are available on Label/ Carton :The details are, Lot No., Use by Date.
Information for use : The details describe for the usage of medical device as well warning and
precautions. Indicates a Medical Device that is intended for one use, or for use on a single patient
during a single procedure. All above given information on the Label and Carton ensure the safe and
efficacious use of device. There is no impact on Patient Safety.
Format No. : CG1 001 /F01 -00
Factory: 876, N.H. No. 8, Hariyala, Kheda-387411, GuJarat, INDIA. Tel.: +91-2694-30400 Fax: +91-2694-304050
Amanta Registered & Corporate Office: Amanta Heallhcare Ltd. (Formerly, Marek B1osciences Ltd .) 5th Floor, Heritage, Nr. Gujarat Vidhyapith , Ashram Road, Ahmedabad-380014, Gujarat, INDIA. Tel. +91-79-30017500 Fax: +91-79-30017600 Email: [email protected] Website: www.amanta.co.in
CIN: U24139GJ1994PLC023944
Amanta Healthcare Limited, Kheda. URGENT - FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION
Notification and Modification to Labelling Page No. : 2 of 4
Traceability of Name and Address of Manufacturer ;
Neutral Code provided by Licensing Authority of India, which are available on the Label.
Neutral Code is: GUJ/DRUG/G/1 080
Viz. Address of Manufacturing Site:
AMANT A HEAL THCARE LTD. (Formerly, MARCK BIOSCIENCES LTD.),
Factory: 876, N.H. No. 8, Hariyala, Kheda-387 411 , Gujarat, India.
Tel. : +91-2694-304000.
FAX. : +91-2694-304050.
Distributed By :
Address
Tel.
FAX
Suggestive Actions :
Medikit Limited
Medikit Limited,
Unit 1 Newporte Business Park Bishops Road ,
Lincoln, Lincolnshire
LN24SY, UK
+44 (0)1522 513512
+44 (0) 1522 549658
The product in the market with current label do not have any impact on safety parameters . We are
requesting you to be a vigilant on Batches which we have already sent to you . We are in-process of
revising the Labels and Cartons w.r.t. EC Directives. In case of any problems I queries, please
contact us.
Please refer Annex - 1 for List of Batches sent by us to you from JAN-2014 to till date.
Format No. : CG1001/F01-00
Factory: 876, N.H. No.8, Hanyala, Kheda-387411, Gu]arat, INDIA. Tel.: +91-2694-30400 Fax. +91-2694-304050
Amanta Registered & Corporate Office: Amanta Healthcare Ltd. (Formerly, Marek Biosciences Ltd.) 5th Floor, Heritage, Nr. Gujarat Vidhyapith , Ashram Road . Ahmedabad-380014 , Gujarat, INDIA. Tel.: t91-79-30017500 Fax: t91-79-30017600 Email: [email protected] Website: www.amanta.co.in
CIN: U24139GJ1994PLC023944
Amanta Healthcare Limited, Kheda. URGENT - FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION
Notification and Modification to Labelling Page No. : 3 of 4
We sincerely apologize for any inconvenience and thanking you in advance for your cooperation.
The under sign confirms that th is notice has been notified to the appropriate Regulatory Authorities.
Amanta Healthcare Limited apologizes for any inconveniences caused by this problem .
Sincerely,
Mr. Sanjaykumar J. Chauhan
AVP - Quality & RA
Copy to :
1- Competent Authority: UK- MHRA
2- Notified Body : SGS UK
Format No. : CG 1001 /F01 -00
Factory: 876, N.H. No.8, Hanyala, Kheda-387411, Gu)arat, INDIA. Tel.: +91-2694-30400 Fax. +91-2694-304050
Amant a Registered & Corporate Off1ce: Amanta Healthcare Ltd. (Formerly, Marek B1osciences Ltd.) 5th Floor, Heritage, Nr. Gujarat Vidhyapith, Ashram Road. Ahmedabad-380014, Gujarat, INOlA. Tel.: +91-79-30017500 Fax: +91-79-30017600 Email: [email protected] Website: www.amanta.co.in
GIN: U24139GJ1994PLC023944
Amanta Healthcare Limited, Kheda. URGENT - FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION
Notification and Modification to Labelling Page No. : 4 of 4
Customer Receipt Verification Card
Fill the receipt verification card and immediately e-mail or Fax us at:
e-mail: info@amanta .co.in , sumit tripathi@amanta .co .in , ra [email protected] .in
Fax No.: +91-2694-304050.
FSN Number FSN/NS/15/004.
Commercial Name of Affected Product Emergency Sterile Eye Wash (Sodium chloride 0.9% w/v Ph.Eur)
Name of Customer
Date of Receipt
Signature , Date & Seal of company
Medikit Limited
Unit 1 Newporte Business Park Bishops Road,
Lincoln , Lincolnshire
LN24SY, UK
Format No. : CG1001/F01 -00
Factory: 876, N.H. No. 8, Hariyala, Kheda-387411, Gujarat, INDIA. Tel.: +91-2694-30400 Fax: +91-2694-304050