[Federal Register Volume 61, Number 182 (Wednesday, September 18, 1996)]
[Notices]
[Pages 49147-49148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0166]


Pasca Plasma Center, Inc.; Revocation of U.S. License No. 1015

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. 1015) and the 
product license issued to Pasca Plasma Center, Inc., (Pasca) for the 
manufacture of Source Plasma. Pasca has facilities in Berkeley, 
Oakland, and Richmond, CA. In a letter to FDA dated July 7, 1993, Pasca 
submitted U.S. license No. 1015 for revocation.

DATES: The revocation of the establishment license (U.S. License No. 
1015) and the product license became effective on August 4, 1993.

FOR FURTHER INFORMATION CONTACT: Valerie A. Windsor, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license 
(U.S. License No. 1015) and the product license issued to Pasca at the 
following locations for the manufacture of Source Plasma: (1) 1796 
University Ave., Berkeley, CA 94703 (U.S. License 1015-003); (2) 650 E. 
14th St., Oakland, CA 94606 (U.S. License 1015-001); and (3) 2316 
MacDonald Ave., Richmond, CA 94804 (U.S. License 1015-002). Pasca's 
mailing address is: 650 E. 14th St., Oakland, CA 94606.
    FDA inspected Pasca's Richmond facility from December 1, 1992 
through December 11, 1992, and its Oakland facility from March 22, 
1993, through April 2, 1993. In addition to the inspections, FDA 
conducted investigations which included interviews with individuals

[[Page 49148]]

knowledgeable in the daily operations of the Oakland, Richmond, and 
Berkeley facilities. As a result of these inspections and 
investigations, FDA determined that there were numerous deviations from 
the standards established in the license as well as the applicable 
Federal regulations.
    The inspections and investigations indicate that Pasca repeatedly 
deviated from donor protection standards which are intended to assure a 
continuous and healthy donor population and to assure the continued 
safety, purity, potency, and quality of the products manufactured. 
Deviations at the Richmond and Berkeley facilities included, but were 
not limited to, the following: (1) At the Richmond facility, failure to 
assure the suitability of the donor would be determined by a qualified 
licensed physician on the day of collection from the donor as required 
by 21 CFR 640.63; (2) at the Richmond facility, failure to determine 
that donors were in good health on the day of donation as required by 
21 CFR 640.63(c); (3) at the Richmond facility, failure to assure that 
a qualified licensed physician explained the hazards of the 
plasmapheresis procedure to the prospective donor as required by 21 CFR 
640.61; (4) at the Richmond and Berkeley facilities, violation of 
general donor suitability standards as required by 21 CFR 640.63(d); 
and (5) at the Richmond and Berkeley facilities, failure to assure that 
the skin of the donor at the site of phlebotomy was prepared by a 
method that gives maximum assurance of a sterile container of blood as 
required by 21 CFR 640.64(e). Deviations identified at the Oakland 
facility included: (1) Failure to provide adequate space for private 
and accurate examinations to determine their suitability and good 
health as donors as required by 21 CFR 606.40(a)(1); (2) failure to 
assure that facilities are maintained in a clean and orderly manner as 
required by 21 CFR 606.40; and (3) failure to determine the suitability 
of a donor by means of medical history, tests and physical exam as 
required by 21 CFR 640.63(a) and (c).
    FDA's inspections and investigations also revealed that Pasca's 
operations were not in compliance with Federal regulations governing 
establishment standards and current good manufacturing practices 
(CGMP's). Deviations included the following: (1) Pasca and its 
responsible head failed to properly train and ensure the competent 
performance of its employees as required by 21 CFR 600.10 and 21 CFR 
606.20; (2) at least one employee at the Berkeley facility was not 
provided with the proper training needed to perform his assigned 
duties; (3) despite not having attended training programs or read the 
standard operating procedures (SOP's), employees at the Berkeley 
facility were required to sign training forms that indicated that they 
had read the SOP's or participated in training programs; and (4) 
management was aware that employees at the Berkley facility conferred 
with each other during a recent test to determine the correct answers. 
In addition, Pasca employees at the Berkeley facility seriously 
departed from CGMP's by routinely squeezing saline into the whole blood 
bags during collection, to shorten the collection time for a full bag, 
and directly reinfusing whole blood into donors from whom an excess of 
whole blood had been collected.
    FDA's inspections and investigations also revealed that at both the 
Richmond and Berkeley facilities, Pasca violated general donor 
suitability standards defined in 21 CFR 640.63(d). Pasca's violations 
included the following: (1) Pasca employees routinely accepted 
donations from donors who appeared to be under the influence of 
alcohol; (2) Pasca failed to determine that donors were in good health 
on the day of donation as required by 21 CFR 640.63(c); and (3) Pasca 
failed to assure that the skin of the donor at the site of phlebotomy 
was prepared by a method that gives maximum assurance of a sterile 
container of blood as required by 21 CFR 640.64(e) in that Berkeley 
facility employees failed to routinely perform the arm scrub at the 
phlebotomy site for 30 seconds as required by the SOP, and, at the 
Richmond facility, a donor's arm was scrubbed for only 15 seconds which 
was inconsistent with the SOP that required a 30-second arm scrub to be 
performed in concentric circles.
    Because these deviations represented a danger to health, FDA 
suspended Pasca's establishment and product licenses at the Oakland 
location by letter dated April 16, 1993, and at the Berkeley and 
Richmond locations by letter dated May 10, 1993. Subsequently, Pasca 
informed FDA that it was discontinuing the manufacture of products at 
all facilities. In a letter to FDA dated July 7, 1993, Pasca submitted 
its license for revocation.
    FDA has placed copies of the letters discussed above on file under 
the docket number found in brackets in the heading of this notice with 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. These documents are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.
    Accordingly, under 21 CFR 601.5, 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. 1015) and the product 
license for the manufacture of Source Plasma issued to Pasca at the 
Berkeley, Oakland, and Richmond locations were revoked, effective 
August 4, 1993.
    This notice is issued and published under 21 CFR 601.8, and the 
authority delegated to the Director, Center for Biologics Evaluation 
and Research under 21 CFR 5.67.

    Dated: August 28, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-23873 Filed 9-17-96; 8:45 am]
BILLING CODE 4160-01-F