This whole process is so frustrating. I believe (could be off by a bit) it has been more than a year now since the FDA found what they deemed wrong at that 3rd party manufacturer. Had to wait for the CRL, then wait for a meeting with the FDA, then take time to put together another submission, and now wait for re-inspection, and then wait for possible approval. Ridiculous. A lot more red tape and complications than what I was used to in my small business. Health inspector dreamed up some violation, I fixed it right in front of him and tada. I'll never forget the moron we had that wrote us up for not having a mop sink. Now this was not a food establishment (vitamins in sealed bottles) and we had all carpet on the floor with a small bathroom that was vinyl. Went out and bought a mop sink, stuck it in a corner, never hooked it up, and piled stuff around it so he would never see and the next month all was fine. Just have to play the game.
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