Fw: Frequent hold ups by US FDA

From: Bill Cole (wmcole@erols.com)
Date: Fri Sep 29 2006 - 10:35:51 PDT


Group:

Here is a message from Mr. David Eisenberg of Anresco that I think worth while passing on to everyone. It is another "wrinkle" in how USFDA Import Districts approach dealing with consultants and other persons/organizations outside the importer/broker/shipper triangle. It basically bolsters the point I was making in my second - and clarifying - e-mail, namely: the procedure of a lot of import officers is to stick with a method which has worked for them in the past. An integral part of this method is:
  Don't deal with anyone you don't have to; and the fewer people/organizations involved in matters like detentions, the easier the whole process will go.
Of course, that is not necessarily always the case. But I think the point is well taken.

Regards to all,

Bill Cole

----- Original Message -----
From: MICROTRACE@aol.com
To: wmcole@erols.com
Sent: Friday, September 29, 2006 12:11 PM
Subject: Re: Frequent hold ups by US FDA

Attn: Mr. William Cole

In the past, some FDA Districts have required that my analytical lab have "Power of Attorneys" signed by importer clients before discussing technical matters with them. In general, we have been able to discuss such matters without one.

A critical issue to private labs doing DWPE (Detention Without Physical Examination) sampling and analysis is that we want FDA to advise the private lab of any deficiencies before advising importers of such so we can try to correct submissions immediately, as often these are trivial. When the FDA advises the importer first, the private lab can be at professional liability risk unfairly.

Please pass this message on if you feel it merits it.

With best wishes.

David Eisenberg
Chairman
Anresco,Inc.
San Francisco, LA, Florida, NY etc.

tel. 1-415-822-1100 ex 11



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