Hi everyone,
Background: we have a fully operational QMS.
Need: For business reasons, we need to provide a service to another business which consists of a short-term storage for finished medical products, not related to what we do and not intended for the US market. That other business is the legal manufacturer and we don't perform any work or quality related activity. In short, we receive and ship out the product ?as is?; nothing more, nothing less.
Question: Will it be acceptable on FDA inspector if we write a memo explaining and exempting these products from our quality controls? In other words, is it possible to justify ?double standard? by a memorandum?
Thanks in advance!!
Shimonv
P.S. A better alternative would be to update the storage and receiving inspection SOPs to reflect this irregular handling, but frankly there are more important things we would like to do.
Background: we have a fully operational QMS.
Need: For business reasons, we need to provide a service to another business which consists of a short-term storage for finished medical products, not related to what we do and not intended for the US market. That other business is the legal manufacturer and we don't perform any work or quality related activity. In short, we receive and ship out the product ?as is?; nothing more, nothing less.
Question: Will it be acceptable on FDA inspector if we write a memo explaining and exempting these products from our quality controls? In other words, is it possible to justify ?double standard? by a memorandum?
Thanks in advance!!
Shimonv
P.S. A better alternative would be to update the storage and receiving inspection SOPs to reflect this irregular handling, but frankly there are more important things we would like to do.
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