[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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