From: Geary, Nathaniel
Sent: Wednesday, July 23, 2003 4:19 PM
To: Druckman, Michael; Zamora, Armando; Butler, Jennie C
Cc: McKeever, Paula; Ripley, Stephen
Subject: [Docket No. 2220N-0232] Universal Reagents, Inc. (URI)

Memorandum for the File

Universal Reagents, Inc. [Docket No. 2003N-0232]

 

I was contacted by phone by Ms Priscilla A. (Ann) Hoppe, Consultant, 404-248-0002.  She left a voice mail, and I returned her call the same day, July 23, 2003. 

 

Ms Hoppe, a former FDA employee, has been hired by URI to advise them on the matters in the Notice of Opportunity for Hearing (NOOH) on a Proposal to Revoke U.S. License No. 0887 (68 FR 41162, July 10, 2003).  Ms. Hoppe said that they are not disputing the facts stated in the NOOH.  However, she did want to get an idea about how serious the matter was before expending large sums of money on consultants and attorneys; and if I thought the owner would be given another chance.  She stated that the owner, who was not present, was not aware of the false documents and had nothing to do with the falsification of those documents.

 

I advised her that FDA could not prejudge the matter, but would have to await the firm’s response.  FDA considers this to be a serious matter that culminated in publication of the NOOH.  I consulted with Armando Zamora, CSO, on my response; and left a voice mail at Ms Hoppe’s office, confirming the response on July 23, 2003.  I invited her to call me back if she had further questions.

 

Nathaniel L. Geary, CSO

CBER/RPS