U.S. Food and Drug Administration
FDA Consumer magazine
January-February 2001
Table of Contents
Summaries of Court Actions are given pursuant to Section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce.
Summaries of Court Actions are prepared by the Office of the Chief Counsel, Food and Drug Administration.
PRODUCT: Calrose Rice, at Columbia, Maryland,
(D.MD.); Civil Action No. 99-CV-3366.
CHARGED 12-9-99: While held for sale after shipment in interstate commerce,
at Hanmi Inc., within the meaning of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. Section 342(a)(4), the articles of food were adulterated in that they
were held under unsanitary conditions whereby they may have become contaminated
with filth.
DISPOSITION: The articles were destroyed. (F.D.C. No. 67293; S. No. 72119, 72120;
S.J. No. 1)
PRODUCT: Oxygen, Compressed USP, at Aberdeen,
South Dakota, (D.S.D); Civil Action No. CIV98-1025.
CHARGED 6-16-98: While held for sale after shipment of one or more of their
components in interstate commerce, at Evergreen Supply, Inc., Aberdeen South
Dakota, within the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
Section 351(a)(2)(B), the articles of drug were adulterated in that the methods
used in, and the facilities and controls used for their manufacture, processing,
packing, and holding did not conform to, and were not operated or administered
in conformity with, current good manufacturing practice to assure that such
drugs meet the safety requirements of the Act and have the identity and strength,
and meet the quality and purity characteristics which they purport and are represented
to possess.
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67233; S. No. 98-717-099;
S.J. No. 2)
PRODUCT: Oxygen, Compressed USP, at Crofton,
Maryland, (D.Md.); Civil Action No. S-99-2142.
CHARGED 7-16-99: While held for sale after shipment of one or more components
in interstate commerce, at American Home Medical, Inc., Crofton, Md., the articles
of drug were adulterated in that the methods used in, and the facilities and
controls used for, their manufacture, processing, packing, and holding did not
conform to, and were not operated or administered in conformity with, current
good manufacturing practice to assure that such article of drug meets the safety
requirements of the Federal Food, Drug, and Cosmetic Act, and has the identity
and strength and meets the quality and purity characteristics which it purports
and is represented to possess.
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67276; S. No. DOC
42008; S.J. No. 3)
PRODUCT: Smokeless Artificial Cigarette (E-Z Quit),
at Riverdale, New York; Civil Action No. 00 Civ. 4069.
CHARGED 5-31-00: While held for sale after shipment in interstate commerce,
at E-Z Quit Inc., Riverdale, New York, within the meaning of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. Section 352(f)(1), the article of drug was
misbranded because its labeling failed to bear adequate directions for use,
and it is not exempt from such requirement under 21 C.F.R. Part 201.115, because
it is an unapproved "new drug," and that as a result of the foregoing, the article
of drug, including its components, labeling and packaging is subject to seizure,
forfeiture and condemnation pursuant to 21 U.S.C. Section 334.
DISPOSITION: The articles were destroyed. (F.D.C. No. 67413; S. No. 69909 et
al.; S.J. No. 4)
PRODUCT: T3 Metabolite, at Mobridge, South Dakota,
(D.S.D.); Civil Action No. CIV00-1015.
CHARGED 6-5-00: While held for sale after shipment of one or more of their components
in interstate commerce, at Mass Quantities, Inc., Mobridge, South Dakota, within
the meaning of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 352
(f)(1), the articles of drug were misbranded because they did not bear adequate
directions for use and are not exempt from such requirement under 21 C.F.R Section
201.115.
DISPOSITION: The articles were destroyed. (F.D.C. No. 67405; S. No. 730; S.J.
No. 5)
PRODUCT: Trimethobenzamide, 5,212 boxes, at Elk
Grove Village, Ill., (N.D. Ill.); Civil Action No. 98-C1376.
CHARGED 3-6-98: While held for sale after shipment of one or more of their components
in interstate commerce at Solopak Laboratories, Inc., within the meaning of
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 351(a)(2)(B), the
articles of drug were adulterated in that the methods used in, and the facilities
and controls used for, their manufacture, processing, packing, and holding did
not conform to and were not operated and administered in conformity with current
good manufacturing practice to assure that such drugs meet the safety requirements
of the Act and have the identity and strength, and meet the quality and purity
characteristics, which they purport and are represented to possess.
DISPOSITION: The articles were destroyed. (F.D.C. No. 67228; S. No. 98-761-363/366;
S.J. No. 6)
PRODUCT: Various Articles of Drug for Human and Veterinary
Use, etc., at Amarillo, Texas, (N.D. Tex.); Civil Action No. 2-00-CV-067-J.
CHARGED 12-29-99: While held for sale after shipment of one or more of their
components in interstate commerce, at Oribi, Inc., dba Meridian Chemical & Equipment,
Amarillo, Texas, within the meaning of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. Section 351(a)(2)(9), the articles were adulterated in that the
methods used in, and the facilities and controls used for, their manufacture,
processing, packing, and holding did not conform to, and were not operated and
administered in conformity with current good manufacturing practice to assure
that such drugs meet the safety requirements of the Act and have the identity
and strength, and meet the quality and purity characteristics, which they purport
and are represented to possess.
DISPOSITION: The articles were destroyed. (F.D.C. No. 67401; S. No. 38291 et
al.; S.J. No. 7)
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