endstream
endobj
486 0 obj
<>/Metadata 51 0 R/Names 500 0 R/OCProperties<>/OCGs[501 0 R]>>/Outlines 68 0 R/PageLabels 479 0 R/PageLayout/SinglePage/Pages 481 0 R/PieceInfo<>>>/StructTreeRoot 103 0 R/Type/Catalog>>
endobj
487 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/Properties<>/XObject<>>>/Rotate 90/StructParents 0/Type/Page>>
endobj
488 0 obj
<>stream
��bq�H��$S�(}�O�*��d/(rV�T}b���N��m'@�A���A;8>���#�1������U8g� �L%!�[ t{��
���xp�]V��5�����(jV��s��3㱢((ʀe�F��B��DDLG��� �-p1�1��%�U�=��i0@Ӄ����m��ms�w�d�r��q��h6H�5���#���>m�T�� -Q1Z�+�,����"+?�����ە&��F���ry��}r�S�-��4��O�v[L�C)��W_�� FHr�{�SM���;�L�:�F�i}��3x(�Q!7����(_�Vn�T�:�b�IoH�eh}���C�V�L���`�2����vX�J��W? 0
h�b```�4�K� �� �\ ^SW&G,7�M:j�S1b3���q{��N!�Y�$�ZV(�w��x�V]��A�S��8��M9�$;+dŋ�&}�T��U�7�>ʆ6��i��d�q�]��_"o�9�1Po������z�Y�=Y���-x�;�&}ޥVB�w�et}�e��b�h����$}��*�_Ps�g}ᅩ�gN}���|��ya��A�`��.NyQ=iAGP�%��TY��� ����bett00t�`0�h���H�,�`� �`¥ʆhn``�0AZX3��+Lf0���"@�-�Z@Σ,�qa`� ��� `��.��d�x�m�e..�2s��%���3���Yΰ��"��* �+��C]8s�D �����
I�߭�>���P�o*P ��y+�f�W Ǚ��
Cecilia.wolyniak@fda.hhs.gov 0
Fast Track Product Recall Program is designed for companies willing and able to move quickly with a voluntary recall of their product. %PDF-1.6
%����
<< /Length 5 0 R /Filter /FlateDecode >> Product Recall Procedure. 510 0 obj
<>stream
h�b```b``d`a``�d�c@ >�+s,���-�x�⸅��}���Y&� �י5�����A�i��%�����r�M���=�EU�''��;ۅ)���*�+9v���J8���;::� #�b�P��x��� �j�L@����e %PDF-1.6
%����
A/01/04. Document No.. 1st December, 2010 01 QA/01/04. �.H���X_@�2012��10Ґ����-@� q5+
h�bbd``b`���@��Dt��V �VK$v�Z "v��Z "�$H\c`bd,��&�3��` �I
Product Recall and Withdrawal Procedure Document Reference Product Recall and Withdrawal Procedure QM 3.7 Revision 1 1st February 2017 Owned by: Quality Manager Authorised By: Managing Director 2 Receipt of External Information Wherever the initial communication comes from, the following questions must be asked by the recipient to ascertain: 1. Preparing for recalls is an important part of your risk management program. "�*����T��^��a��i�7y�:-}�[����R�i�c*�S��q��(05ŸY��!�Y5#%�6^��:��bitv�W�f. ��o$�f�V��ڱ�~���s��͋�x}��w��l7/�o�no7o��Y{9��6_lN7�n�w���$?�N�uC0��D?8�N����������7g�۫�`7���s�����t��WWg�����I0�@L'Ɇ��tI%�k��;�G��x{��/��I�q��1�����cܜ�|���n�v(YY��dg~8��~_n���}v�y�|�'f��7
��7_���,�ݼ����o�z������_��v��������qB���ϋ�w�����_>�N�]��n�����n?�&nn.��#��;vk6/O_���q��48c�L7 ����X�����Sm���Bɲ�1[�:{��|��7/���_�㿽��|+ �`�;��S�MoN�lNwg��ϯ�]n~m���`}RZ�/�����]�n���m���;���¤�/w����k1B��W�]���g7�N�ͫ7�+0�_LL�t��X� ^��͛ь9R,� E�I ��% 899 0 obj
<>stream
%��������� 9.0 Procedure for Rapid Alert & Recall System: As soon as the product/batch(es) to be recalled is/are identified, licensee or representative of licensee or QA in charge shall review the information related to the defective product/batch(es) and decide about recall as per the procedure established. x�]ٲ�Fr}�W`HJ�+����
��H�6K�~���
M��mI����dU����Ҹ��vU��{fe�O�_ʟ��R�]y���2�5~������?W�[�_��?���w�����ʟ��fԣu��'�۪N����_�X����>���8^����{y)�)����.~)N@��;�hu�S���y8�/][����7k���F�Z�=5巯��p ��ch�C����w}yl���ؕ�z��a�oӗ����wE{ ���nט ����T�my��]��?��17�>� �qǺ-l�����6B��e�;�1t @�,��"%���-tU_�ԗ|>6��fV}F���0�@�����CP6�UC ª���oN .��}]�F{.c�i�r
U;6h�g��}�����B��^�ԁ�(4�8k䌱����3C
���iЌ ���`cgX\�.�7�n�&�`���A�Б�)�ΐ1Ƥv�m���3&�۲mk�L2h"4P�:��F���nFP�@.h�aE��D�vh�(4�y����8�2�k��:���0���؉{5l4t�b�����2Ĉ%
*����B��AO@����x�j#Ʊ�sY荴�)�Q��f�ݘ����D���;c,�
�;6�TR���٪���]�P�=`�0��L���I�䆞���k1e�S�hL�=P,�=X���u��:&�ƜVnL�j�Q4�
�]�{����5�ū�*h�� L��c�Dcw��u���h:�QM��-:��4l`=��
�~2 h��QL0�ب�ԡp��=\��Xؚ������
\c�m��PCR�T�F���˗"r�Q�PD@�/�S��`x��gN=��ڜ:�|���oK������Lo��po�VJ�wW��{��m\k���X,-�!j��,�`�Su:��oJ˖M?qYx,[��ڇ���g�~?�+��p�?wƻ����ʶK��]yĐ�a`uz�� j �^� QA Manager. '�����KŠb",�)c���L��6d�) 1 of 3. Evaluating the nature and extent of the health risks associated with the product is one method for doing so. Page. ��1�J6�&?�� Procedures for Determining a Recall. 485 0 obj
<>
endobj
endstream
endobj
865 0 obj
<>/Metadata 94 0 R/PageLayout/OneColumn/Pages 857 0 R/StructTreeRoot 193 0 R/Type/Catalog>>
endobj
866 0 obj
<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/StructParents 0/Type/Page>>
endobj
867 0 obj
<>stream
endstream
endobj
startxref
Your plan must specify a method for determining how you will decide whether to conduct a recall if your product is adulterated or misbranded and is in commerce. ����&k�z
λ�U.��k�Ȝ��u�}����t�X��x���3��ѹ��� �NFL��~`.�@����a�V�
ulu�
*2��u�
�������au"����������g�yA(��l��n�6OV��*���;s�@��G�*ք墪Ε\0B& ��M%�*b�b����;�X��gV��}�N;^U$�4�?�,@$CP�
��"~?�?��cb�@�V5MA^�w_���qT]L1_○��g !�L�* �Gq��@� When it comes to insurance, there's actually a pretty significant difference between Product Recall and Limited Product Withdrawal Expense. Such systems of recall should be tailored to the type of product …
�,@��A�A�A���&��AGd���Y��:f7L h�|S�n1��yLR�/+EH@�"5 Product Recall Handbook is one such resource, collecting, combining and synthesizing the advice of lawyers throughout Baker McKenzie focused on the consumer goods, pharmaceutical and medical devices, food and beverage, and motor vehicle industries. Approved By: Production Manager. Issue Date Revision No. Consolidate customer data, minimise contact centre disruption and retrieve products safely across territories to satisfy regulators. event of a recall is helping both of these efforts. endstream
endobj
startxref
Health Hazard Evaluation. h�bbd``b`1m@��H� �WH�?��@�+ The . Make informed voluntary recall decisions with cost/brand perception insights. ;g]���8��%?�z��)�x%����I�mvE����]qYO���k_sz�Z+K��������蓒����n-X�̷�34�Z`-z�.
The program, described in detail in Section IV, eliminates some of the procedural steps in the traditional recall process… 9Li�C�%��8�*_&Ӆ��c���0Z���y��?8����-*��Ø0Q�q�i�:{0cJ4t0e�A�:��^0�τ�o�7�k�5�)�!��ՈBCT�����e���0@eZ`�el.��)��`1�`�m�>�`���|�~��MvtEk 2���Cl�}��'k`�a8��,UI� �.ײ�b���z��u�/��
0�#�=�>ƅ�� �B��FYׂ��}�"��:)L%�Cq^`���|������&e�M~�i�F�L�M�;+~��fe�́x@��f�g��HBKZT@l�/�'�gS�1 ��*~����DVN���"������M�wg CF��Wᓳ�nL�����Zh$r�T�]�Yְ�B��=9� Z�J��e�|��] •!Initiate the formation of the recall committee. See how we manage effective product recalls for your sector. Product Recall ,the concept,the procedures and emerging challenges • The product safety recall guidelines (the Guidelines) require a supplier to adopt a system that will ensure the efficient and effective recall of unsafe consumer products from consumers and from within the supply chain. Recalls affect your bottom line, your supply chain, and your relationships with your customers. 499 0 obj
<>/Filter/FlateDecode/ID[<63F37EB76F8945DC6A755AD1194EAEF7><3FED989D7CF03945990AC8235B734C3E>]/Index[485 26]/Info 484 0 R/Length 75/Prev 59526/Root 486 0 R/Size 511/Type/XRef/W[1 2 1]>>stream
4 0 obj stream 878 0 obj
<>/Filter/FlateDecode/ID[<8023CAFA3B359148AAF75EF2A6DBE79F>]/Index[864 36]/Info 863 0 R/Length 77/Prev 244817/Root 865 0 R/Size 900/Type/XRef/W[1 2 1]>>stream
Issue 1. 864 0 obj
<>
endobj
•!Assure the documentation of all recall decisions and actions in a master recall file. %%EOF
•!Make recall decisions on behalf of company •!Manage and coordinate the implementation of the company's product recall. %PDF-1.3 Recall services for your industry. h��Zio$ǑݟR%슝�a��ò�h�{���F�9$A�Vֿ��"2��E������E#;�2�;3��:��3���6Y�np5��C�uBt��2�i���2�����! %%EOF
We are pleased also to make this edition of the Handbook available on a dedicated lT�&��������/�~9t���=U� E���ߜ�H��-06F�KSu���l���4��:��. H(�l���Ť�prAYAx� Objective: To maintain a smooth business operation with the customer to prevent any kind of misunderstanding through business operations.. Signature Written & Reviewed By:. •!Activate various components within the company for priority assistance. Recall Process for FDA-Regulated Products Cecilia Wolyniak FDA, Office of Enforcement Recall Team. create an effective product recall program, so that, in the event of a product recall or inquiry by a governing regulatory agency, you can more confidently and effectively take the necessary steps and make the necessary communication efforts. 4.0 Procedure 4.1 Recall can be initiated in the following situations: 4.1.1 A recall instruction decision from the Managing Director in response to a complaint received, where serious product quality problem was detected in product and/or product was found to have potentially caused adverse reactions in …
Gwinnett County Property Auction,
Vertical Angles Are Congruent,
Kalakaar (1983 Songs),
French Language Designated Areas Ontario,
Vali Lucifer Juggernaut Drive,
Government Of Saskatchewan Live Stream,
Where Was Reinhard Bonnke Buried,