[Docket No. 93NÄ0416]

AVRE Inc.; Revocation of U.S. License No. 1074Ä003

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. 1074Ä003) 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. 1074Ä003)
and the product license became effective November 8, 1993.

FOR FURTHER INFORMATION CONTACT: Jean M. Olson, Center for Biologics
Evaluation and Research (HFMÄ635), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852Ä1448, 301Ä594Ä3074.

SUPPLEMENTARY INFORMATION: FDA announces the revocation of the establishment
license (U.S. License No. 1074Ä003) 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 «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 «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 1074Ä003 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. 1074Ä003) 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 (HFAÄ305), Food and Drug Administration, rm.
1Ä23, 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. 1074Ä003) 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. 94Ä37 Filed 1Ä3Ä94; 8:45 am]

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