[Federal Register Volume 59, Number 97 (Friday, May 20, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-12291] [[Page Unknown]] [Federal Register: May 20, 1994] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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