[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Page 62776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30915]



[[Page 62776]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0445]


Intermountain Health Care, Inc.; Revocation of U.S. License No. 
0729

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the establishment license (U.S. License No. 0729) and the 
product licenses issued to Intermountain Health Care, Inc., for the 
manufacture of Whole Blood, Red Blood Cells, Cryoprecipitated AHF, 
Plasma, and Platelets. The firm voluntarily surrendered its licenses as 
part of a Consent Decree of Permanent Injunction.

DATES: The revocation of the establishment license (U.S. License No. 
0729) and the product licenses became effective October 8, 1997.

FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license 
(U.S. License No. 0729) and product licenses issued to Intermountain 
Health Care, Inc., Eighth Ave. and C St., Salt Lake City, UT 84143, for 
the manufacture of Whole Blood, Red Blood Cells, Cryoprecipitated AHF, 
Plasma, and Platelets. The revocation affects all locations under the 
license which included: Salt Lake City, Ogden, Provo, Logan, and St. 
George, UT.
    FDA inspected Intermountain Health Care, Inc., facilities located 
in Ogden, UT, December 3 through December 18, 1996; Provo, UT, February 
13, 1997, through March 14, 1997; and Salt Lake City, UT, March 17, 
1997, through April 18, 1997. These inspections revealed numerous 
serious deviations from applicable Federal regulations and the 
standards established in the firm's license. Based on the serious 
nature of the deficiencies identified, FDA determined that a danger to 
health existed. The deficiencies noted included, but were not limited 
to, the following: (1) Failure to operate equipment in a manner for 
which it was designed (21 CFR 606.60(a)); and (2) failure to perform 
and document a thorough investigation, including conclusions and 
followup, of: (a) Any unexplained discrepancy or the failure of any lot 
or unit to meet any of its specifications; (b) any reports of 
complaints of adverse reactions regarding each unit of blood or blood 
product arising as a result of either blood collection or transfusion 
(21 CFR 606.100(c) and 606.170(a)); (c) failure to adequately determine 
donor suitability (21 CFR 640.3(b)); (d) failure to adequately prepare 
the skin of the donor at the site of phlebotomy by a method that 
provides maximum assurance of a sterile container of blood (21 CFR 
640.4(f)); (e) failure to assure that personnel responsible for the 
collection, processing, compatibility testing, storage, or distribution 
of blood or blood products have adequate training and experience 
(Sec. 606.20(b) (21 CFR 606.20(b))); and (f) failure to maintain 
complete, accurate, and concurrent records (21 CFR 606.160).
    FDA determined that these deficiencies constituted a danger to the 
public health that warranted suspension under 21 CFR 601.6(a). These 
deficiencies also demonstrated management's failure to exercise control 
over the establishment in all matters relating to compliance and to 
ensure that personnel are adequate in number, adequately trained and 
supervised, and have a thorough understanding of the procedures that 
they perform, as required by 21 CFR 600.10(a) and (b) and 
Sec. 606.20(a) and (b).
    In a letter to the firm dated April 28, 1997, FDA suspended the 
establishment license (U.S. License No. 0729) and product licenses for 
the manufacture of Whole Blood, Red Blood Cells, Cryoprecipitated AHF, 
Plasma, and Platelets. As required by a Consent Decree of Permanent 
Injunction signed by the court on July 9, 1997, Intermountain Health 
Care, Inc., waived its opportunity for a hearing, and in a letter to 
FDA dated July 11, 1997, surrendered its licenses.
    FDA has placed copies of the letters previously discussed on file 
under the docket number found in brackets in the heading of this notice 
with the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
These letters are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Accordingly, under 21 CFR 601.5(a), section 351 of the Public 
Health Service Act (42 U.S.C. 262), and under authority delegated to 
the Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
Director, Center for Biologics Evaluation and Research (21 CFR 5.68), 
the establishment license (U.S. License No. 0729) and the product 
licenses for the manufacture of the aforementioned products issued to 
Intermountain Health Care, Inc., were revoked, effective October 8, 
1997.
    This notice is issued and published under 21 CFR 601.8 and the 
redelegation under 21 CFR 5.67(c).

    Dated: November 12, 1997.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-30915 Filed 11-24-97; 8:45 am]
BILLING CODE 4160-01-F