I got the following letter from Steven Rosen, President of Tend Skin, on 14 September 2002. It’s in response to a letter I sent in July about the FDA inspection and warning.
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Hi Andrea,
I apologize for the extreme delay in getting back to you! You were told right that we had a visit from the FDA. We also had a few other agencies in here, all thanks to a former “friend” I’ve known for 20 years and who worked for me.
He tried to set me up for his own financial gain. Here is the FDA story.
They first visited us in Jan. 2001. They would not tell us how they got wind of us. Even a freedom of Information request did not help.
The crux of the 01/01 visit resulted in us having to improve the paperwork we maintained for our manufacturing, i.e. batch reports, label control, validation testing, etc.
The warning letter, which is public information stated that we were making “medical” claims for the topical use of aspirin, which is essentially what the product consists of. Claims we made included acne, cold sores, warts, fungal infections, insect bites, anti-itching, scar reduction, etc.
None of these claims are allowable in the drug monograph for aspirin. to make these claims one would need to go through a New Drug Application which costs a mint and takes several years. At that point, the product would be considered an OTC drug subject to extremely rigid manufacturing standards the agency calls cGMP’s or Current Good Manufacturing Practices.
FDA came back again July 5, 2002, after notifying us of their impending inspection on July 3rd, and found everything ok.
Then unexpectedly, they returned on December 17th, 2001. We found out that the basis of the visit had to do with the Warning Letter from the Jan. 2001 visit…again, the medical claims!
What the investigator did not tell us, but what we later found out when FDA sent all companies they visited a copy of their complete inspection report. The reason for the December visit was “anonymous report #8779”. The report was a complaint mentioning a bird being kept in the production area, falsified logbook entries for samples saved from batches, and people eating in the production area.
Well guess what? The investigator found none of these things. Unfortunately, she found that the claims to some extent were still on our web site and in our literature. Also, we got hammered on validation procedures not in place that we were never told we needed. We had to “voluntarily” dispose of all product in hosue because they said it was “tainted”. We also had to “voluntarily” dispose of all our literature that still had the claims. FDA photographed the entire disposal process.
They also made us do a “voluntary” recall on the distributor level. That was a pain.
We should have only been down for a month in order to establish the procedures they requested. Unfortunately, we had to hire a consultant who knew how to implement the procedures. This “consultant” had his own agenda that wasted a month’s time and a lot of $$$$. We eventually went back and just did what FDA demanded.
For the record, FDA never questioned safety or efficacy. We now market the produgt strictly as a cosmetic, and we have not heard from FDA since they visited in January solely to photograph the disposal of the product we had on hand.
The formula is essentially the same as before.
That’s the gist of the story. Please let me know if you have any further questions and I will be happy to reply…in a much shorter period of time than this took!
Kindest regards,
Dr. Steven Rosen
Pres.
Tend Skin </font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>
