Product Complaints or Adverse Events. 4.1 All individuals reporting a product related complaint should be immediately directed to contact Reliant’s Customer Complaints Group as directed by Reliant. 4.2.1 Reliant shall maintain a system to receive, log, evaluate, categorize, communicate, and follow-up each complaint received. 4.2.2 Reliant shall report any product complaints to Patheon in writing within seven days of receipt of the complaint. 4.2.3 Upon receiving a product complaint for which the subject bottle is still available, Reliant shall issue a return mailer to have the complaint sample returned. 4.2.4 Patheon shall perform a thorough investigation of each product complaint for operations performed at Patheon, and shall make every reasonable effort to provide Reliant with a written report within 45 days, unless a more urgent need is identified and mutually agreed upon (i.e. NDA Field Alert). 4.2.5 Reliant shall be responsible for communication and final correspondence with the complainant, and/or regulatory authorities. 4.2 All individuals reporting an Adverse Event (AE) should be immediately directed to contact Reliant’s Medical Affairs Department as directed by Reliant. 4.2.1 Reliant shall maintain a system to receive, log, evaluate, categorize, communicate, and follow-up each AE received. 4.2.2 Reliant shall maintain all AE files and is responsible for forwarding all appropriate information to Regulatory Agencies. 4.3 Reliant shall be the only authorized group to provide product related responses to the public. 4.4 Should Reliant discover a product related problem, Reliant Quality Department shall provide a written complaint notification to Patheon within 2 business days of the occurrence.
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Product Complaints or Adverse Events. 4.1 All individuals reporting a product related complaint should be immediately directed to contact Reliant’s Customer Complaints Group as directed by on QMCL Reliant.
4.2.1 4.1.1 Reliant shall maintain a system to receive, log, evaluate, categorize, communicate, and follow-up each complaint received.
4.2.2 4.1.2 Reliant shall report any product complaints to Patheon Abbott in writing within seven days of receipt of the complaint.
4.2.3 4.1.3 Upon receiving a product complaint for which the subject bottle is still available, Reliant shall issue a return mailer to have the complaint sample returnedreturned to Abbott at (ADDRESS).
4.2.4 Patheon 4.1.4 Abbott shall perform a thorough investigation of each product complaint for operations performed at PatheonAbbott, and shall make every reasonable effort to provide Reliant with a written report within 45 days, unless a more urgent need is identified and mutually agreed upon (i.e. NDA Field Alert).
4.2.5 4.1.5 Reliant shall be responsible for communication and final correspondence with the complainant, and/or regulatory authorities.
4.2 All individuals reporting an Adverse Event (AE) should be immediately directed to contact Reliant’s Medical Affairs Department as directed by on QMCL Reliant.
4.2.1 Reliant shall maintain a system to receive, log, evaluate, categorize, communicate, and follow-up each AE received.
4.2.2 Reliant shall maintain all AE files and is responsible for forwarding all appropriate information to Regulatory Agencies.
4.3 Reliant shall be the only authorized group to provide product related responses to the public.
4.4 Should Reliant discover a product related problem, Reliant Quality Department shall provide a written complaint notification to Patheon Abbott within 2 business days of the occurrence.
Appears in 2 contracts
Samples: Manufacturing Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)
