Sorry for asking so many questions -
- Is the "Country of Origin" needed to be mentioned on all packaging materials supporting a finished medical device ? We have a customer packagaing that mentions the Customers address in US but does not have specific reference to "Country of Origin". Under what circumstances if the "Country of Origin" required ?
- Being into plastic injection molding for medical devices, we assign a Lot Number for the weekly running of the products but the manufacturing date keeps changing based on the actual date olf molding. Is this practise acceptable to have the same Lot number with different manufacturing dates ? My gut says its fine but when I read the FDA definition of "Lot" I felt it to be not okay.
- We get printed product bags from the supplier and then we pack the product in it and put a sticker having batch details. Is the practise of affixing sticker with product detail acceptable in the US per FDA requirements ? I am asking this question as some countries do not allow stickets and want batch details to be overprinted.