[Federal Register: April 26, 1999 (Volume 64, Number 79)]
[Notices]
[Page 20310-20311]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap99-113]

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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