Inspections, Compliance, Enforcement, and Criminal Investigations
Pure Research Products LLC Response Letter
Pure Research Products LLC
A Division of JA Sichel & Associates, Inc.
6107 Chelsea Manor Court
Boulder, Colorado 80301
toll free: (888) 466-8635
fax: (303) 930-0222
Patricia A. Clark, Compliance Officer
U.S. Food and Drug Administration, Suite 100
300 Pearl Street
Buffalo, New York 14202
Re: FDA Warning Letter
5 June 2006
Dear Officer Clark:
The FDA Warning Letter dated January 26, 2006 was received on February 1, 2006. Directions instructed me to address my reply to Shelly Maifarth, FDA Compliance Officer In Denver, Colorado. On February 2, 2008 Officer Maifarth was contacted by telephone and a meeting was scheduled for Thursday February 9, 2006.
The February 9, 2006 meeting was conducted at 10 :30 A.M. In the conference room of the FDA in Denver, Colorado . Compliance Officers Shelly Maifarth and William H. Sharer, as well as the Director of the Compliance Division, Howard E. Manresa, attended. Officer Maifarth explained the FDA's position and described the regulations relating to the issues.
I asked a series of questions to define and insure that immediate changes would bring our situation Into compliance. Required revisions were initiated immediately. We were delayed by a few days due to [redacted] Officer Sherer was informed of [redacted]. By the end of February, virtually all changes were Implemented.
On Tuesday May 23, 2006 I met with Officer Sherer in his Denver FDA office for a final review and to insure we were in compliance. I was told we are now in compliance. A thank you note was promptly sent to Officer Sherer. On May 26, 2006 Officer Sherer contacted me and asked about this letter and I advised him it would be finalized within a few days.
Is there any significance by the statement at the end of your email letter which reads Supplement: Bottle= 180 capsules with 60mg each $150. Our product Del-Immune V® contains 25mg of active ingredient per capsule, distributed in bottles of 30 capsules and 100 capsules, with respective prices of $19.50 and $49.50.
John A. Sichel, RPh, PD