[packagingguy]

We deal with notified bodies every year at work.

There are specific guidelines laid down in standards from different organizations such ISO, ISTA, ASTM and the like.

With ASTM standards multiple laboratories in different locations determine if the tests are valid. So it shouldn’t matter if you manufacture in Switzerland or Swaziland.

You must conform to the standards.

If the company is not doing so it should be caught by auditors.

It sounds like both were not doing their jobs.

[9422WMR]

“ You must conform to the standards.”
Just go to Mexico or any other central or South American country. Pharmacies are open to the public, no doctor prescription is required. I’m sure all those cheap drugs are top quality generics!/S

[PeterPrinciple]

You must conform to the standards.

If the company is not doing so it should be caught by auditors.

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My understanding is you do a detailed write up of what you say you are going to do. That is the audit. No followup.