[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Notices]
[Pages 306-307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-37]


[[Page Unknown]]

[Federal Register: January 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0416]

 

AVRE Inc.; Revocation of U.S. License No. 1074-003

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. 1074-003) and 
the product license issued to AVRE Inc., (AVRE) for the manufacture of 
Source Plasma. AVRE has several locations. Only the Tacoma location is 
affected by this revocation. In a letter to FDA dated June 30, 1993, 
AVRE requested that its establishment and product licenses at the 
Tacoma location be revoked and thereby waived its opportunity for a 
hearing.

DATES: The revocation of the establishment license (U.S. License No. 
1074-003) and the product license became effective November 8, 1993.

FOR FURTHER INFORMATION CONTACT: Jean M. Olson, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: FDA announces the revocation of the 
establishment license (U.S. License No. 1074-003) and the product 
license issued to AVRE Inc., 10506 Bridgeport Way SW., Tacoma, WA 
98499, for the manufacture of Source Plasma. Other locations under the 
AVRE license are not affected by this revocation. The licenses were 
revoked for the Tacoma location of AVRE only.
     FDA inspected the Tacoma location of AVRE on April 7 through 21, 
1993. During that inspection, FDA observed numerous deviations from the 
standards established in the license as well as the applicable Federal 
regulations. The inspection documented serious deviations from the 
applicable Federal regulations and standards established in the 
license. These deviations included, but were not limited to, the 
following:
    1. Failure to follow adequate written standard operating procedures 
(SOP's) for determining donor suitability (21 CFR 606.100(b)), in that 
four donors were allowed to donate Source Plasma more than twice during 
a 7-day period; five donors were allowed to donate Source Plasma who 
had experienced a weight loss of greater than 10 pounds within a 2-
month period without first being referred to a physician or physician 
substitute; and educational information provided to donors did not 
reference a temperature greater than 100.5  deg.F for more than 10 days 
as a symptom of acquired immune deficiency syndrome (AIDS).
    2. Failure to follow adequate written SOP's for the collection, 
processing, storage, and distribution of blood and blood components for 
further manufacturing (21 CFR 606.100(b)), in that AVRE collected an 
amount of plasma from at least three donors that exceeded the maximum 
volume allowed by AVRE's plasma volume nomogram, AVRE's donor record 
files for at least 20 donors, 6 with multiple donations, did not 
contain photographs; and AVRE did not have its physician or physician 
substitute evaluate one donor who exhibited a temperature below 97.0 
deg.F.
    3. Failure to maintain complete, accurate, and concurrent records 
that clearly traced the steps of each significant procedure in the 
collection, processing, and storage of the blood products so as to 
provide a complete history of work performed (21 CFR 606.160), in that 
AVRE was unable to trace two unit numbers to the donors, AVRE 
misspelled the last name of at least one donor in the deferral file, 
and AVRE had no unit number in its donor record file for at least one 
donation.
    4. Failure to observe, standardize, and calibrate equipment (21 CFR 
606.60(a)), in that during October 1992, AVRE failed to clean the air 
filters on four Autopheresis-C machines.
    FDA determined that the nature of the deficiencies found at AVRE 
showed a pattern of careless disregard for the standards established in 
the license and the Federal regulations that are designed to ensure the 
continued safety, purity, and potency of the manufactured product and 
that willfulness existed. The recent inspection showed that corrective 
actions promised in response to a March through April 1992 inspection, 
which resulted in suspension of AVRE's license, were not implemented or 
were not effective in achieving long-term compliance. In a letter to 
AVRE dated May 27, 1993, FDA delineated the observations listed above, 
provided notice that FDA intended to institute proceedings to revoke 
U.S. License 1074-003 issued to AVRE pursuant to 21 CFR 601.5(b). In 
accordance with 21 CFR 601.5(b), the letter advised AVRE that no 
additional time would be provided to achieve compliance with the 
regulations before FDA would institute proceedings to revoke the 
licenses of AVRE. The letter further announced its intent to offer an 
opportunity for a hearing. In a letter to FDA dated June 30, 1993, AVRE 
voluntarily requested that its licenses for the Tacoma location be 
revoked and thereby waived its opportunity for a hearing. In a letter 
dated November 8, 1993, FDA acknowledged voluntary revocation of the 
establishment license (U.S. License No. 1074-003) and the 
aforementioned product license of AVRE at the Tacoma location only.
    FDA has placed copies of letters relevant to the license 
revocations on file under the docket number found in brackets in the 
heading of this document in the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857. 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 21 CFR 601.5 and 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. 1074-003) and the product 
license issued to the Tacoma location of AVRE Inc., for the manufacture 
of Source Plasma were revoked, effective November 8, 1993.
    This notice is issued and published under 21 CFR 601.8 and under 
authority delegated to the Director of the Center for Biologics 
Evaluation and Research (21 CFR 5.67).

    Dated: December 16, 1993.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 94-37 Filed 1-3-94; 8:45 am]
BILLING CODE 4160-01-F