Please any one can help me on FDA relabeler and repacker FDA requirements? If you have any check list please provide us.

Thank you
Sherley13

First, you need to decide for each element, if it is applicable or not for your quality system. If not, you need to justify it. Once it is applicable, if there is a requirement in the standard to have a procedure in place, you should create a procedure. Otherwise it would be a major NC.

Good Luck,

Yana

You would be better to ask in the forums than in a blog.

How To Ask A Question or Start a Conversation by Starting a New Thread in a Forum

Do remember there is a distinction between a procedure (in general) vs. a *documented* procedure.

We just went through a Stage 1 assessment for ISO 13485,... the question came up, that is...
Q: do all the elements in the QMS Manuel have to have a Quality Procedure... such as 5.0 thru 5.5.3 (11) in all. or can you just refer to QOP 5.6 (that one has a QOP)