[Federal Register Volume 62, Number 3 (Monday, January 6, 1997)]
[Notices]
[Pages 762-763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-186]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0290]


AM-Rho Laboratories, Inc.; Revocation of U.S. License No. 991-001

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. 991-001) and 
the product license issued to AM-Rho Laboratories, Inc., Jacksonville, 
FL, for the manufacture of Source Plasma. In a letter to FDA dated 
April 11, 1996, AM-Rho Laboratories, Inc., voluntarily requested 
revocation of its establishment and product licenses. In a letter dated 
July 3, 1996, FDA informed the firm that the establishment and product 
licenses for its Jacksonville location were revoked.

DATES: The revocation of the establishment license (U.S. License No. 
991-001) and the product license became effective July 3, 1996.

FOR FURTHER INFORMATION CONTACT: Dano B. Murphy, 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. 991-001) and product license for the manufacture of 
Source Plasma of AM-Rho Laboratories, Inc., 4130 Salisbury Rd., suite 
2100, Jacksonville, FL 32216.
    FDA inspected AM-Rho Laboratories, Inc., from October 16, 1995, 
through November 9, 1995. The inspection also involved a concurrent 
investigation that included interviews with individuals knowledgeable 
in the daily operations of the firm. The inspection of the facility and 
concurrent investigation revealed serious deviations from applicable 
Federal regulations. The deficiencies noted included, but were not 
limited to, the following: (1) Failure to properly immunize donors (21 
CFR 640.66) by: (a) Permitting nonphysicians, working without a 
physician present, to inject at least 37 donors with red blood cell 
antigen; (b) immunizing at least one donor during plasmapheresis; and 
(c) permitting nonphysicians to select antigens and schedule 
immunizations; (2) failure to adequately determine donor suitability 
by: (a) Not excluding for the required 8-week period at least 21 donors 
who lost whole blood (21 CFR 640.63(e)); (b) routinely reevaluating 
donor hematocrit without recording the initial hematocrit values; and 
(c) routinely not complying with established standard operating 
procedures that required the cross checking of donors against deferral 
logs; (3) failure to maintain complete, accurate, and concurrent donor 
records (21 CFR 606.160) by: (a) Routinely forging physician's 
signatures on numerous records; (b) not completing maintenance and 
calibration records concurrently with work done; (c) inaccurate 
documentation of red blood cells not returned to the donor; (d) 
documenting as destroyed red blood cells that were returned to the 
donor; and (e) not providing a unit number for certain plasmapheresis 
products; (4) failure to maintain and follow standard operating 
procedures (21 CFR 606.100(b)) by: (a) Inadequately preparing 
phlebotomy sites on at least 25 donors; (b) not following the procedure 
for verifying correct reinfusion of red blood cells; and (c) permitting 
donors to leave the premises before the minimum time for 
postimmunization observation.
    FDA concluded that the serious nature of the deficiencies 
identified during the inspection and during the concurrent 
investigation of AM-Rho Laboratories, Inc., were the direct consequence 
of the establishment's disregard for the applicable regulations and 
standards in the license application. FDA determined that these 
deficiencies constitute a danger to the public health that warranted 
suspension under 21 CFR 601.5(b) and 601.6(a). Additionally, the 
deficiencies noted demonstrated management's failure to exercise 
control over the facility relating to compliance and to assure adequate 
training and supervision of personnel as required by 21 CFR 600.10(a) 
and (b) and 606.20(a) and (b).
    In a November 27, 1995, letter to the firm, FDA suspended the 
establishment license (U.S. License No. 991-001) and product license 
for Source Plasma. In a February 14, 1996, letter to FDA, the firm 
stated it would not seek reinstatement of the suspended license (U.S. 
License No. 991-001) and would destroy all plasma products in 
inventory. In a letter to FDA dated April 11, 1996, AM-Rho 
Laboratories, Inc., requested voluntary revocation of U.S. License No. 
991-001.

[[Page 763]]

    FDA has placed copies of the letters relevant to the license 
revocation on file under the docket number found in brackets in the 
heading of this document 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(a), 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. 991-001) and the product 
license for the manufacture of Source Plasma issued to AM-Rho 
Laboratories, Inc., Jacksonville, FL 32216, were revoked effective July 
3, 1996.
    This notice is issued and published under 21 CFR 601.8 and the 
redelegation at 21 CFR 5.67(c).

    Dated: December 19, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-186 Filed 1-3-97; 8:45 am]
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