[Federal Register Volume 61, Number 180 (Monday, September 16, 1996)]
[Notices]
[Pages 48705-48706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23550]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0169]
Midland County Hospital District; Revocation of U.S. License No.
961
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. 961) and the
product licenses issued to Midland County Hospital District, now doing
business as Permian Basin Regional Center, for the manufacture of Red
Blood Cells, Plasma, and Platelets. In a letter to FDA dated November
1, 1995, the firm voluntarily requested that its establishment and
product licenses be revoked.
DATES: The revocation of the establishment license (U.S. License No.
961) and the product licenses became effective March 14, 1996.
ADDRESSES: Copies of letters from FDA and Midland County Hospital
District may be seen at the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: Annette A. Ragosta, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: FDA conducted an inspection of Midland
County Hospital District, 200 Airport Plaza, Midland, TX 79711-1650,
from March 14 through April 11, 1995. The inspection also involved a
concurrent investigation which included interviews with individuals
knowledgeable about the firm's daily operations. The inspection and
concurrent investigation revealed serious noncompliance with applicable
standards and Federal regulations. Serious deficiencies were reported
in interviews and observed by the investigators in several areas of the
firm's operations. Deviations included, but were not limited to the
following: (1) Failure to collect blood by aseptic methods in a sterile
system to protect against contamination (21 CFR 640.4(f)) in that it
was reported to our investigators that on numerous occasions employees
broke the sterility barrier of blood containers and drained blood into
vacutainer tubes or biohazard containers in order to conceal
overbleeds; (2) failure to follow standard operating procedures for
addressing adverse donor reactions (21 CFR 606.100(b)(9)) in that it
was reported to our investigators that on several occasions employees
continued to bleed donors while the donors were experiencing adverse
reactions; and (3) failure to maintain records concurrently with the
performance of each significant step in the collection, processing,
storage, and distribution of each unit of blood and blood components so
that all steps can be clearly traced (Sec. 606.160(a)(1) (21 CFR
606.160(a)(1))) in that: (a) important donor selection information,
such as vital signs, answers to medical history and high risk behavior
questions, and documentation of hemoglobin checks, was not obtained and
recorded concurrently with each donor suitability determination; (b) it
was reported to our investigators that on several occasions daily
performance checks of equipment were not performed but the records were
completed to indicate that these had been performed
(Sec. 606.160(b)(5)(ii)); and (c) it was reported to our investigators
that, on at least two occasions, maintenance records for the Cobe
Spectra instrument were completed to give the appearance that
maintenance had been performed, when in fact, it may not have been
performed (Sec. 606.160(b)(7)(iv)).
FDA determined that these deviations from Federal regulations
constituted a danger to public health warranting a suspension under 21
CFR 601.6(a). In a letter to Midland County Hospital District, dated
April 20, 1995, FDA detailed the above-described violations and stated
that the firm's management had not effectively fulfilled its
responsibilities to exercise control in all matters relating to
compliance and had not assured that personnel were adequately trained
and had a thorough understanding of the procedures that they were to
perform (21 CFR 600.10(a) and (b) and 606.20(a) and (b)). In the same
letter, FDA suspended the firm's establishment and product licenses for
the manufacture of Red Blood Cells, Plasma, and Platelets. In a letter
dated November 1, 1995, Midland County Hospital District voluntarily
requested that its licenses be revoked. The agency acknowledged the
request for a voluntary revocation of the establishment and product
licenses in a letter dated March 14, 1996.
The agency has placed copies of letters from FDA, dated April 20,
1995, and March 14, 1996, and a letter from Midland County Hospital
District, dated November 1, 1995, on file under the docket number found
in brackets in the heading of this document in the Dockets Management
Branch (address above). These documents are available for public
examination in the Dockets Management Branch (address above) between 9
a.m. and 4 p.m., Monday through Friday.
Accordingly, under section 351 of the Public Health Service Act (42
U.S.C. 262), 21 CFR 601.5, 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. 961), and the product
licenses for the manufacture of Red Blood Cells, Plasma, and Platelets,
issued to Midland County Hospital District, Midland, TX, now doing
business as Permian Basin Regional
[[Page 48706]]
Center, were revoked, effective March 14, 1996.
This notice is issued and published under 21 CFR 601.8 and the
redelegation at 21 CFR 5.67.
Dated: August 28, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-23550 Filed 9-13-96; 8:45 am]
BILLING CODE 4160-01-F
