Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N-0391]

Central Georgia Plasma Labs, Inc.; Opportunity for Hearing on a

Proposal to Revoke U.S. License No. 0649-001

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for hearing on a proposal to revoke the establishment

license (U.S. License No. 0649-001) and the product license issued to

Central Georgia Plasma Labs, Inc., for the manufacture of Source

Plasma. The proposed revocation is based on significant noncompliance

with certain provisions of the biologics regulations specified in this

document.

DATES: The firm may submit a written request for a hearing to the

Dockets Management Branch by June 20, 1994, and any data or information

justifying a hearing by July 19, 1994. Other interested persons may

submit written comments on the proposed revocation by July 19, 1994.

ADDRESSES: Submit written requests for a hearing, any data and

information justifying a hearing, and any written comments on the

proposed revocation to the Dockets Management Branch (HFA-305), Food

and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD

20857.

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 is proposing to revoke the establishment license (U.S. License

No. 0649-001) and the product license issued to Central Georgia Plasma

Labs, Inc., 652 Third St., Macon, GA 31201, for the manufacture of

Source Plasma. The proposed revocation is based on the failure of

Central Georgia Plasma Labs, Inc., and its responsible management to

conform to the applicable standards and conditions established in its

license and the requirements of 21 CFR parts 600, 601, 606, and 640.

FDA inspected Central Georgia Plasma Labs, Inc., on February 1

through 5, 8 through 12, and 17, 1993. During that inspection, FDA

observed numerous significant deviations from the standards established

in the license as well as the applicable Federal regulations. Such

standards are designed to ensure the continued safety, purity, and

potency of the product.

The inspection showed that Central Georgia Plasma Labs, Inc.,

failed to adequately determine donor suitability. These deviations

included, but were not limited to, the following: (1) In violation of

21 CFR 640.63(c)(9), Central Georgia Plasma Labs, Inc., collected

Source Plasma from a donor after the donor had tested repeatedly

reactive for antibody to hepatitis C virus (HCV); (2) in violation of

21 CFR 640.65(b)(1)(i), Central Georgia Plasma Labs, Inc., failed to

collect a four month sample for serum protein electrophoresis testing

from a donor; and (3) in violation of 21 CFR 640.65(b)(5) for eight

people during a 7-day period, Central Georgia Plasma Labs, Inc.,

removed whole blood in excess of acceptable amounts, in excess of 2,000

milliliters (mL) in donors weighing less than 175 pounds and in excess

of 2,400 mL in donors weighing 175 pounds or more.

The inspection showed that Central Georgia Plasma Labs, Inc.,

failed to follow written standard operating procedures (SOP's) for the

collection, processing, storage, and distribution of Source Plasma. In

violation of 21 CFR 606.100, Central Georgia Plasma Labs, Inc., failed

to follow its SOP's for identifying and recovering previous donations

from three donors who tested repeatedly reactive for hepatitis B

surface antigen. As a result, Central Georgia Plasma Labs, Inc., failed

to find and cull one unit for one donor, three units for a second

donor, and five units for a third donor. During November and December

1992, there were 81 overbleeds whereby Central Georgia Plasma Labs,

Inc., removed, at one time, amounts of whole blood from a donor in

excess of the volumes established in its SOP's in violation of 21 CFR

606.100 and 21 CFR 640.65(b)(6). The inspection showed that Central

Georgia Plasma Labs, Inc., failed 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. Such

deviations included, but were not limited to, the following: (1) In

violation of 21 CFR 606.160(b)(3)(i), Central Georgia Plasma Labs,

Inc., collected plasma from a donor testing repeatedly reactive for

antibody to HCV, and recorded in the plasma shipping records that the

unit was shipped; however, the Central Georgia Plasma Labs, Inc.'s,

disposition records show that the same unit was destroyed; (2) in

violation of 21 CFR 606.170(a), Central Georgia Plasma Labs, Inc., kept

inadequate records of an investigation for a March 1991, incident where

a donor was infused with red blood cells from another donor; and (3) in

violation of 21 CFR 606.160(a)(1), information concerning overbleeds

was not recorded in the Whole Blood records concurrent with the

performance of the work.

Central Georgia Plasma Labs, Inc., failed to adequately maintain

its walk-in freezer used for the storage of Source Plasma in violation

of 21 CFR 606.60(a). On a number of occasions in 1992, the temperature

in the storage cabinet went above -20 deg.C two or more times in a 72-

hour period, but Source Plasma stored in the freezer during those

periods was not relabeled as required by 21 CFR 640.70(b).

FDA's inspectional observations clearly show a persistent pattern

of significant noncompliance, on the part of Central Georgia Plasma

Labs, Inc., with the standards established in the license and the

Federal regulations. FDA made similar observations of Central Georgia

Plasma Labs, Inc.'s, significant deviations from compliance with

established standards in September 1981, June 1982, June 1983, October

1986, July 1989, April 1990, and January 1992, inspections.

The seriousness of Central Georgia Plasma Labs, Inc.'s,

noncompliance with established standards was brought to its attention

in letters from FDA dated September 1981, June 1982, July 1983,

November 1986, July 1988, November 1989, and notice of intent to revoke

letters dated April 1992 and May 1993. On May 15, 1992, Central Georgia

Plasma Labs, Inc., responded to the April 1992, letter by submitting a

training plan. Among other things, the plan provided that certified

employees would be reviewed semiannually, and employees who failed a

final exam given at the end of a training module would repeat the

course. However, inspections reveal that Central Georgia Plasma Labs,

Inc., has not properly implemented the plan. Of the three individuals

that have been certified since May 15, 1992, none have received a

semiannual review. The one individual that failed a final exam for a

module has not been required to repeat the course.

Although Central Georgia Plasma Labs, Inc., has repeatedly promised

to take corrective actions concerning these and other observations,

followup inspections have revealed that effective long term corrective

actions have not been taken. FDA has no assurance that Central Georgia

Plasma Labs, Inc.'s (the firm's), proposed corrective actions will be

properly implemented and that the firm will not continue to engage in

repeated noncompliance with established standards designed to ensure

the continued safety, purity, and potency of the product. Consequently,

FDA finds that Central Georgia Plasma Labs, Inc., has willfully not

complied with the standards established in the license and the

applicable regulations. Accordingly, FDA is not required to provide

Central Georgia Plasma Labs, Inc., with an opportunity to correct its

deficiencies and achieve compliance with the applicable standards (21

CFR 601.5(b)).

FDA is now issuing a notice of opportunity for hearing pursuant to

21 CFR 12.21(b) on a proposal to revoke the establishment license (U.S.

License No. 0649-001) and the product license issued to Central Georgia

Plasma Labs, Inc.

In a letter dated May 27, 1993, and issued pursuant to 21 CFR

601.5(b), FDA notified Central Georgia Plasma Labs, Inc., and its

responsible head, of FDA's intent to revoke the product license and

U.S. License No. 0649-001, and announced its intent to offer an

opportunity for hearing. In a letter dated June 1, 1993, Central

Georgia Plasma Labs, Inc., advised FDA that the firm did not wish to

waive its opportunity for a hearing.

FDA has placed copies of documents supporting the proposed license

revocation on file with the Dockets Management Branch (address above)

under the docket number found in brackets in the heading of this

notice. These documents include the following: List of Observations

(Form FDA-483) from inspections of February 1 through 5, 8 through 12,

and 17, 1993, and of January 22 through February 21, 1992; Central

Georgia Plasma Labs, Inc., letters of February 26 and May 15, 1992, and

February 22 and June 1, 1993; FDA letters of November 3, 1989, April

30, 1992, and May 27, 1993; and other relevant FDA letters. These

documents are available for public examination in the Dockets

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Central Georgia Plasma Labs, Inc., may submit a written request for

a hearing to the Dockets Management Branch by June 20, 1994, and any

data and information justifying a hearing must be submitted by July 19,

1994. Other interested persons may submit comments on the proposed

license revocation to the Dockets Management Branch by July 19, 1994.

The failure of a licensee to file a timely written request for a

hearing constitutes an election by the licensee not to avail itself of

the opportunity for hearing concerning the proposed license revocation.

FDA procedures and requirements governing a notice of opportunity

for hearing, notice of appearance, request for a hearing, grant or

denial of a hearing, and submission of data and information to justify

a hearing on a proposed revocation of a license are contained in 21 CFR

parts 12 and 601. A request for a hearing may not rest upon mere

allegations or denials but must set forth a genuine and substantial

issue of fact that requires a hearing. If it conclusively appears from

the face of the data, information, and factual analyses submitted in

support of the request for a hearing that there is no genuine and

substantial issue of fact for resolution at a hearing, or if a request

is not made within the specified time or in the required format or with

the required analyses, the Commissioner of Food and Drugs will deny the

hearing request, making findings and conclusions that justify the

denial.

Two copies of any submissions are to be provided to FDA, except

that individuals may submit one copy. Submissions are to be identified

with the docket number found in brackets in the heading of this

document. Such submissions, except for data and information prohibited

from public disclosure under 21 CFR 10.20(j)(2)(i), 21 U.S.C. 331(j),

or 18 U.S.C. 1905, may be seen in the Dockets Management Branch

(address above) between 9 a.m. and 4 p.m., Monday through Friday.

This notice is issued under the Public Health Service Act (sec. 351

(42 U.S.C. 262)) and the Federal Food, Drug, and Cosmetic Act (secs.

201, 501, 502, 505, 701 (21 U.S.C. 321, 351, 352, 355, 371)) and under

authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)

and the Director, Center for Biologics Evaluation and Research (21 CFR

5.67).

Dated: May 11, 1994.

Michael G. Beatrice,

Deputy Director, Center for Biologics Evaluation and Research.

[FR Doc. 94-12291 Filed 5-19-94; 8:45 am]

BILLING CODE 4160-01-F