[Federal Register Volume 64, Number 79 (Monday, April 26, 1999)]
[Notices]
[Pages 20310-20311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0672]


Iatric Corp.; Revocation of U.S. License No. 0416

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. 0416) and the 
product license issued to Iatric Corp. for the manufacture of 
Allergenic Extracts. In letters to FDA dated June 26 and June 30, 1998, 
the firm voluntarily requested revocation of its establishment and 
product licenses. In a letter dated August 28, 1998, FDA informed the 
firm that the establishment and product licenses were revoked.

DATES: The revocation of the establishment license (U.S. License No. 
0416) and the product license became effective August 28, 1998.

FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license 
(U.S. License No. 0416) and the product license for the manufacture of 
Allergenic Extracts issued to Iatric Corp., 2330 South Industrial Park 
Dr., Tempe, AZ 85282.
     FDA inspected Iatric Corp. from April 7 through April 11, 1997. 
The inspection of the facility revealed

[[Page 20311]]

serious deviations from applicable Federal regulations and the 
standards established in the firm's license. The deficiencies noted 
included, but were not limited to, the following: (1) Failure of each 
person engaged in the manufacture, processing, packing, or holding of a 
drug product to have the necessary education, training, and experience 
to perform that person's assigned functions (21 CFR 211.25(a)); (2) 
failure to thoroughly investigate any unexplained discrepancy in drug 
product production and control records or the failure of a batch to 
meet any of its specifications (21 CFR 211.192); (3) failure to 
establish separate or defined areas or other control systems for 
manufacturing and processing operations to prevent contamination or 
mixups (Sec. 211.42(c) (21 CFR 211.42(c) and 600.11(a))); (4) failure 
to establish and follow appropriate written procedures designed to 
prevent microbiological contamination of drug products purporting to be 
sterile and to ensure that such procedures include validation of any 
sterilization processes (21 CFR 211.113(b)); (5) failure to report 
adverse experience information (21 CFR 600.80(c)); (6) failure to 
establish laboratory controls that include scientifically sound and 
appropriate specifications, standards, sampling plans, and test 
procedures designed to ensure that components, drug product containers, 
closures, in-process materials, labeling, and drug products conform to 
appropriate standards of identity, strength, quality, and purity (21 
CFR 211.160(b)); (7) failure to provide adequate space for the orderly 
placement of equipment and materials to prevent mixups between 
different components, drug product containers, closures, labeling, in-
process materials, or drug products, and to prevent contamination 
(Sec. 211.42(b)); (8) failure to establish and/or follow written 
procedures for production and process controls designed to ensure that 
the drug products have the identity, strength, quality, and purity they 
purport or are represented to possess and to ensure that such 
procedures, including any changes, are drafted, reviewed and approved 
by the appropriate organizational units and reviewed and approved by 
quality control (21 CFR 211.100); (9) failure to maintain buildings 
used in the manufacture, processing, packing, or holding of a drug 
product in a good state of repair (21 CFR 211.58); and (10) failure to 
demonstrate that adequate ventilation is provided (21 CFR 211.46(a)).
     These deficiencies demonstrated the management's failure to 
exercise control over the establishment in all matters relating to 
compliance and to ensure that personnel are adequately trained and 
supervised and have a thorough understanding of the procedures that 
they perform, as required by 21 CFR 600.10(b) and 211.25. FDA 
determined that these deficiencies constitute a danger to the public 
health that warranted suspension under Secs. 601.5(b) and 601.6(a) (21 
CFR 601.5(b) and 601.6(a)). By letter dated April 25, 1997, to Iatric 
Corp., FDA suspended the firm's establishment license (U.S. License No. 
0416) and product licenses for Coccidioidin U.S.P. and Allergenic 
Extracts. The letter stated that FDA intended to proceed under 
Sec. 601.6(b) to revoke the establishment license and the product 
licenses. By letter dated May 13, 1997, Iatric Corp., voluntarily 
revoked their product license for Coccidioidin U.S.P. (BioCox). In a 
letter to FDA dated May 14, 1997, Iatric Corp., requested that the 
matter of license revocation for Allergenic Extracts be held in 
abeyance.
     In the Federal Register of November 14, 1997 (62 FR 61129), FDA 
announced the voluntary revocation of the product license for the firm 
for the manufacturer of Coccidioidin, U.S.P (BioCox), which resulted 
from the same deficiencies noted previously. In a letter to Iatric 
Corp., dated June 24, 1998, FDA stated that the extensive failure of 
the firm to maintain control over the manufacturing process of the 
licensed products; and the continual failure of the firm, after 
numerous verbal and written promises, to provide an adequate corrective 
action plan subsequent to the April 25, 1997, suspension letter 
demonstrated a distinct pattern of noncompliance with those 
requirements designed to ensure the safety, purity, identity, and 
quality of licensed product and, therefore, could no longer grant the 
firm's May 14, 1997, request that the revocation of license be held in 
abeyance. In the same letter, FDA provided notice to the firm of FDA's 
intent to initiate proceedings to revoke all establishment and product 
licenses encompassed under U.S. License No. 0416 issued to Iatric Corp. 
and to issue a notice of opportunity for hearing under Sec. 601.5(b). 
In letters dated June 26 and June 30, 1998, Iatric Corp. requested 
voluntary revocation of U.S. License No. 0416, and thereby waived its 
opportunity for a hearing.
     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, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. 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. 0416) and the product 
license for the manufacture of Allergenic Extract issued to Iatric 
Corp., Tempe, AZ 85282, were revoked effective August 28, 1998.
     This notice is issued and published under 21 CFR 601.8 and the 
redelegation at CFR 5.67(c).

    Dated: April 12, 1999.
Mark Elengold,
Deputy Director, Operations, Center for Biologics Evaluation and 
Research.
[FR Doc. 99-10289 Filed 4-23-99; 8:45 am]
BILLING CODE 4160-01-F