Donor Referral Services cited for record-keeping gaps, procedural flaws.(BLOOD AND BIOLOGICS)

Donor Referral Services, Raleigh, NC Atlanta District

Donor Referral Services, a human tissue recovery firm, was unable to supply FDA investigators Randy Clarida and Michelle Haamid records pertaining to the eligibility of donors from which tissue was recovered during the months of May through December 2005, the team reported following an inspection June 28-30, 2006.

Donor Referral also had no records regarding donor suitability, including testing and screening records, for the period July 2003 through March 2004, according to the 7-item 483 the inspectors issued.

The firm acknowledged that it had recovered tissue from a number of donors during these periods, Clarida and Haamid wrote.

The investigators further found that Donor Referral Services had no procedures for screening for donor eligibility and no procedures for shipping and distributing tissue during the period May through December 2005.

Donor Referral was cited for failure to retain records regarding donor suitability for at least 10 years beyond the date of transplantation, distribution, disposition or expiration. The firm no longer had records for the donors from which tissue had been recovered during July 2003 through March 2004, nor did they know where those records might be.

No documentation of environmental controls was available for tissue recovered after May 25, 2005, through December 2005.

Donor Referral Services, Raleigh, NC, 6/28-30/07, Doc.110129M, $3 plus retrieval

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