[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
