Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003.
- United States. Congress. Senate. Committee on Governmental Affairs
- Date:
- 2003
Licence: Public Domain Mark
Credit: Tissue banks : the dangers of tainted tissues and the need for federal regulation : hearing before the Committee on Governmental Affairs, United States Senate, One Hundred Eighth Congress, first session, May 14, 2003. Source: Wellcome Collection.
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![EXHIBIT #10 ONEITEN LAL - ed DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION STRICT ADORESS AXO PHONE NUMBER OATEQR OF NEPECTION 60 Eighth Street NE 03/25/2002 - 04/12/2002 Atlanta, GA 30309 FaNMéBet - (404). 253-1161 Fax: (404) 253-1202 3001451326 NAME ANG TINLE OF INONIDUAL TO WHO REPORT SSUED To: James C. Vander Wyk, VP of Quality Assurance/Regulatory Affairs AR StREES ACORESS Cryolife Inc — 1655 Roberts Bivd Nw GTy, STATE, ZP CODE, COUNTRY a TYPE ESTABLISHMENT (XSPECTED Kennesaw, GA 30144 : Medical Device Manufacturer/HumanTissue Processor 2: ae | DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: The observations noted in this Form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and ail violations of the quality system requirements. hia, i - OBSERVATION 1 A process whose results cannot be filly verified by subsequent inspection and test has not been fully validated and approved according to established procedures. ; @ Specifically, The review of the validation studies for the following: Aartomated Microbial Detection System [aka BacT/ALERT 3D] revealed the following. a. There are no positive and negative controls used with the samples tested for this study. b. Validation work does not support the reduction of culture incubation from 14 days to 7 days. c. There was no growth promotion testing of the BacT/ALERT media bottles and the Anaerobic Blood Agar plates as part of the validation. d. No study data is available to support worse case situation utilizing one inoculated media in the geometric mean of each incubator drawer in a module. Annotation: Under consideration. OBSERVATION 2 Sampling plans are not based on valid statistical rationale. Specifically, the 228 sample size used for the final method study to compare culture results of the BacT/ALERT system versus old method NBOO1 is not based on a valid stastical rationale. OBSERVATION 3 There is no documentation of the revalidation of a process conducted in response to changes or process deviations. Specifically,the firm did not re-validate when they changed the BacT/ALERT anaerobic media bottle from regular media to the ananerobic FAN bottle on or about 3/15/02. DATE ISSUED SEE REVERSE b, ) o> 04/12/2002 OF THIS PAGE Y INTHE C- 00619](https://iiif.wellcomecollection.org/image/b32221514_0115.jp2/full/800%2C/0/default.jpg)
