[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
