[Federal Register Volume 62, Number 220 (Friday, November 14, 1997)]
[Notices]
[Pages 61129-61130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30028]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0431]
Iatric Corp.; Revocation of Product License for Coccidioidin, USP
(BioCox)
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 biological product license issued to Iatric Corp.,
Tempe, AZ, for the manufacture of Coccidioidin, USP (BioCox). In a
letter to FDA dated May 13, 1997, Iatric Corp. voluntarily requested
revocation of its product license for Coccidioidin, USP (BioCox). In a
letter dated June 25, 1997, FDA informed the firm that its product
license for Coccidioidin, USP (BioCox) was revoked.
DATES: The revocation of the product license became effective June 25,
1997.
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 product license issued
to Iatric Corp., 2330 South Industry Park Ave., Tempe, AZ 85282, for
the manufacture of Coccidioidin, USP (BioCox).
FDA inspected Iatric Corp. on April 7 through 11, 1997. The
inspection of the facility revealed serious deviations from applicable
Federal regulations. The inspection also included a concurrent
investigation concerning the interstate distribution of the product.
The deficiencies noted included, but were not limited to, the
following: (1) Failure
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of each person engaged in the manufacturing, processing, packing, or
holding of a drug product to have the necessary education, training,
and experience to perform their assigned functions Sec. 211.25(a) (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 21 CFR
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 assure 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 assure 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) failures to establish and/
or follow written procedures for production and process controls
designed to assure that the drug products have the identity, strength,
quality, and purity they purport or are represented to possess and to
assure 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)).
Based on the results of FDA's inspection and investigation, FDA
determined that the firm's Coccidioidin, USP (BioCox) was adulterated
within the meaning of section 501(b) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351(b)) and in violation of section
351(a) of the Public Health Service Act (the PHS Act) (42 U.S.C.
262(a)). These products were also misbranded within the meaning of
section 502(a) of the act (21 U.S.C. 352(a)).
FDA concluded that the nature of the deficiencies noted at Iatric
Corp. were the direct consequence of a disregard for the applicable
regulations and standards in the license application. These
deficiencies also demonstrated 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 Sec. 211.25. FDA determined that these deficiencies constitute a
danger to the public health that warranted suspension under
Sec. 601.5(b) (21 CFR 601.5(b)) and 21 CFR 601.6(a).
In a letter to the firm dated April 25, 1997, FDA suspended the
establishment license (U.S. License No. 0416) and product license for
Coccidioidin, USP (BioCox). In a letter dated May 13, 1997, Iatric
Corp. requested voluntary revocation of its product license for the
manufacture of Coccidioidin, USP (BioCox).
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 Sec. 601.5(a), section 351 of the PHS Act, 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 product license issued to Iatric Corp.
for the manufacture of Coccidioidin, USP (BioCox) was revoked,
effective June 25, 1997.
This notice is issued and published under 21 CFR 601.8 and the
redelegation at 21 CFR 5.67(c).
Dated: October 31, 1997.
Mark Elengold,
Acting Deputy Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-30028 Filed 11-13-97; 8:45 am]
BILLING CODE 4160-01-F