Finally, the FDA inspector arrived in coffee shop. We were a bit prepared as he called late in the day prior to visit. The staff had given very little time to prepare. Clean all equipment, tools and facilities. It was very short, but at least, not a horrible suprise visit which was what we expected. I also managed to arrive at site, heared his comments and tend to his needs.
To make the long story short, the application was not approved. Not yet until we comply to all his recommendations that should accomplish within a specified time frame. Else, application will be considered void. A repeat from the start.
I will not list all comments. It is an eye popping wall of text when written. Instead I am sharing important pointers that might help with your own establishment.
1) The process starts from ” dirtiest to cleanest”. There are only two plant design to be considered. The first is straight line and the second is “L” shape.
2) No to old fragile incandescent bulb, CFL bulb, flouresence lamp, and new LED bulb. If they are to be used, they should be enclosed in protective cover. He recommended the new polycarbonate LED bulb as good alternative.
3) Implement lot numbering for traceability.
4) Prepare a product recall procedure.
5) Always keep a reference sample. It is very important in case the situation goes out of hand. I did a rough estimate and it gonna result to lots of sales lost. Something should be done to compensate for this.
6) Proper record keeping and filing. This guy asks a lot of thing. You better be prepared.
8) Only things that are needed in specific production area should exist. Everything in excess are considered source of contaminant.
9) Observed proper hygiene. We hear it everytime and yet we often fail.
10) Build those comfort room outside the production area.
11) Consider conducting a regular internal and external audit.
There are still lot more to say but I guess that’s all the most important. Hope it helps.