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

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]

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