That link didn't work so here is another one.
FDA warning letter
Interesting to see FDA come down so hard on Ton's for a non-sterile product. FDA has been getting very strict in this area.
The way this works is FDA conducts an inspection. The objectional observations from the inspection are formally presented to Tom's on an FDA-483 form. Tom's then formally responded to the observations. FDA issued a warning letter listing the observations responses that they disagreed with and why. If FDA does not like the warning letter response then the next step is consent decree.
FDA does like to use certain language in their warning letters and 483s. Like the "recovery for PA in multiple water samples from June 21 to October 22". Multiple samples could be two or 200 so it's hard to tell the level of contamination that was found. I'd infer that Tom's hasn't had PA growth in their water system for 2 years or else FDA would have mentioned it. Seems like it's under control now, but FDA wants them to take action. It's a frustrating part of dealing with FDA inspections.
1. Tom's found microbial growth in a product. They retested and didn't find growth so they concluded it must have been lab contamination. FDA said the investigation was inadequate. I'm dealing with this issue at my work. How much growth is allowed in a non-sterile product. It's a very difficult issue. The product is not made aseptically so there's bound to be some microbial growth but when we find growth, we have a big investigation. Microbial growth investigations are the most difficult ones. It's almost impossible to tell if the growth came from the lab or from the product. You can retest the product all you want and find no growth but it's almost impossible to say the growth you found on that one sample was definitely lab contamination.
They validated their water system but didn't fully get the PQ approved before using the system. That seems to have made FDA angry and I don't blame them. Systems must not be commissioned until they are fully validated and signed off. They finally fully approved the document after FDA asked for it. FDA is pushing them hard to validate and test their water system to a higher standard. From the sounds of it, to purified water, USP, which they should have already been doing.
2. They came down hard on them for having dirty floors/corners.
3. We investigate every complaint at my company and I'm a lead investigator for anything related to the manufacture of the product. We would definitely investigate any odor complaint pronto.
Calling for them to bring in a consultant is pretty serious. FDA is not happy with Tom's.
