Summaries of Court Actions

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.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Peeled shrimp, frozen, 124 cases more or less, at Tampa, Fla. (M.D. Fla.); Civil Action No. 95-12-CIV-T-21(E).
CHARGED 1-5-95: While held for sale, after shipment in interstate commerce, at Americold Cold Storage, Inc., stored to the account of Crystal Cove Seafood Corp., the articles of food were adulterated in that they consisted in whole or in part of a decomposed substance by reason of the presence therein of decomposed shrimp--402(a)(3).
DISPOSITION: Pursuant to a default judgment, the articles were destroyed. (F.D.C. 67037; S. No. 94-681-943; S.J. No. 1)

PRODUCT: Peeled shrimp, quick frozen, 86 cases more or less, at Tampa, Fla. (M.D. Fla.); Civil Action No. 95-129-CIV-T-23(B).
CHARGED 1-30-95: While held for sale, after shipment in interstate commerce, at Seaboard Cold Storage, Inc., stored to the account of Crystal Cove Seafood Corp., the articles of food were adulterated in that they consisted in whole or in part of a decomposed substance by reason of the presence therein of decomposed shrimp--402(a)(3).
DISPOSITION: Pursuant to a default judgment, the articles were destroyed. (F.D.C. No. 67053; S. Nos. 94-681-944/945; S.J. No. 2)

PRODUCT: Shrimp, frozen, 695 cases, at Los Angeles, Calif. (C.D. Calif.); Civil Action No. 97-7985.
CHARGED 10-30-97: While held for sale, after shipment in interstate commerce, at Los Angeles Cold Storage, in Los Angeles, Calif., the article of food was adulterated in that it consisted in part of a decomposed shrimp substance by reason of the presence therein of decomposed shrimp--402(a)(3).
DISPOSITION: The government filed and was granted a motion for summary judgment that sought the condemnation, forfeiture and destruction of the shrimp. This was appealed to the Ninth Circuit but was subsequently dropped. The article of food was destroyed. (F.D.C. No. 67209; S. No. 97-768-223; S.J. No. 3)

Medical Devices

PRODUCT: Dry Heat Sterilizers, 29 cases, at Mecklenberg County, N.C. (W.D. N.C.); Civil Action No. 3:95CV1-H.
CHARGED 1-9-95: This was a seizure of dry heat sterilizers and steam sterilizer autoclaves. The devices, located at D.A. Kadan Co., in Mecklenberg County, N.C., were adulterated in that they had been classified under 21 U.S.C. Section 360c(f) as class III devices, and there were no approved premarket approval applications in effect pursuant to 21 U.S.C. Section 360j(g)--501(f)(1)(B).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66911; S. No. 93-700-673; S.J. No. 4)

DEFENDANT: TPLC, Inc., doing business as Telectronics Pacing Systems ("Telectronics"), a corporation, and James W. Dennis, an individual, at Miami Lakes, Fla. (S.D. Fla.); Civil Action No. 95-1075.
CHARGED 5-19-95: While held for sale, after shipment of one or more of their components in interstate commerce, at Telectronics, in Miami Lakes, Fla., and Englewood, Colo., the articles of device, implantable cardiac pacemakers and pacemaker leads, were adulterated in that the methods, facilities or controls used to manufacture, process, pack, label, and hold such devices did not conform to and were not operated and administered in conformity with current good manufacturing practice regulations--501(h).
DISPOSITION: Pursuant to a consent decree of permanent injunction, Telectronics shut down its operation until the Food and Drug Administration found that they were in compliance with the Food, Drug, and Cosmetic Act. The company has since sold its pacemaker operations to St. Jude. (F.D.C. No. 67050; S. No. Doc. 95-711-341; S.J. No. 5)

Drugs/Human Use

PRODUCT: Anthocaine Injection 2%, 8000 mL vials, at Arcadia, El Monte, and Irwindale, Calif. (C.D. Calif.); Civil Action No. 95-0810.
CHARGED 2-8-95: While held for sale, after shipment of one or more of their components in interstate commerce, at Anthony Products Co., doing business as Anpro Pharmaceutical, in Arcadia, El Monte, and Irwindale, Calif., 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--501(a)(2)(B).
DISPOSITION: The firm destroyed some products and reconditioned other products by returning the raw materials to the original manufacturer. (F.D.C. No. 67032; S. No. 94-684-392; S.J. No. 6)

PRODUCT: An Article of Drug, 480 cases, more or less, each case containing 6/64 bottles, labeled in part: Jogging In A Jug, at Muscle Shoals, Ala. (N.D. Ala.); Civil Action No. CV-94-HM-1209-NW.
CHARGED 5-18-94: While held for sale, after shipment in interstate commerce, at Third Option Laboratories, Inc., in Muscle Shoals, Ala., the article was a new drug within the meaning of 21 U.S.C. Section 321(p), and no approval of an application filed pursuant to 21 U.S.C. Section 355(b) was in effect for such drug--505(a). The article was misbranded in that its labeling failed to bear adequate directions for use, and it was not exempt from such requirements under 21 CFR 201.115 since it was an unapproved new drug--502(f)(1).
DISPOSITION: A consent decree of condemnation, destruction and permanent injunction was entered May 17, 1995, and Third Option Laboratories, Inc., remitted a penal bond in the amount of $100,000. On Oct. 27, 1995, based upon the government's motion and the defendant's performance on all the conditions in the consent decree, the court ordered that the penal bond be canceled and discharged. (F.D.C. No. 66906; S. No. 94-650-492; S.J. No. 7)

PRODUCT: Immune Serum Globulin for IV Use, A/D . . . 20 cases, at Miami, Fla. (S.D. Fla.); Civil Action No. 99-0583.
CHARGED 2-26-99: While held for sale, after shipment of one or more of its components in interstate commerce, at Radix Group International (doing business as AEI Customs Brokerage Services), in Miami, Fla., the article of drug was misbranded in that its labeling failed to bear adequate directions for use--502(f)(1).
DISPOSITION: Final default judgment of forfeiture was granted and the article was destroyed. (F.D.C. No. 67260; S. No. DOC 27719/27722; S.J. No. 8)

PRODUCT: L'Aprina (Topical Aspirin), 20 unlabeled cases, at Chantilly, Va. (E.D. Va.); Civil Action No. 98-1453-A.
CHARGED 10-2-98: While held for sale, after shipment of one or more of its components in interstate commerce, at Chantilly Enterprises, Inc., or the related firms L'Aprina International, Inc., and Quality Health Products, Inc., in Chantilly, Va., the articles of the unapproved new drug were misbranded in that their labeling failed to bear adequate directions for use and they were not exempt from such a requirement under 21 CFR 201.115--502(f)(1).
DISPOSITION: Pursuant to a default decree of condemnation, forfeiture and destruction, the articles were destroyed. (F.D.C. No. 67253; S. No. 19650, 19651; S.J. No. 9)

PRODUCT: Oxygen, at Wichita, Kan. (D. Kan.); Civil Action No. 98-1292-MLB.
CHARGED 8-17-98: While held for sale, after shipment of one or more of their components in interstate commerce, at Brown Welding Supply, in Wichita, Kan., 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 ensure that such drugs met the safety requirements of the Food, Drug, and Cosmetic Act and had the identity and strength, and met the quality and purity characteristics, which they purported and were represented to possess--501(a)(2)(B). The articles, Nitrous Oxide USP and Medical Air USP, were misbranded in that their labels failed to bear an accurate statement of the quantity of the contents--502(b)(2).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67236; S. No. 98-688-713; S.J. No. 10)

INJUNCTION ACTIONS

DEFENDANT: Ackrad Laboratories, Inc., a corporation, and Bernard Ackerman, an individual, at Cranford, N.J. (D. N.J.); Civil No. 95-CV-6149.
CHARGED 12-4-95: While held for sale, after shipment in interstate commerce, at Ackrad Laboratories, Inc., in Cranford, N.J., the articles of device (catheter irrijet syringes) were adulterated in that the methods used in and the facilities or controls used for their manufacture, packing, storage, or installation were not in conformity with current good manufacturing practice regulations--501(h).
DISPOSITION: A consent decree of permanent injunction was entered Dec. 6, 1995. The firm came into initial compliance as specified in the decree in 1996. The consent decree is still in place and the district office continues to monitor the firm's compliance. (Inj. 1349; S. No. 94-675-214; S.J. No. 11)

DEFENDANT: K & K Merchandising Group, Inc., and Stuart J. Kerzner, at New York, N.Y. (S.D. N.Y.); Civil No. 97Civ0461.
CHARGED 1-22-97: This case was a civil action for injunctive relief and monetary penalties brought by the United States of America, against defendants K & K Merchandising Group, Inc. (K & K), and its principal officer, Stuart J. Kerzner, as a result of defendants' repeated violations of the Radiation Control for Health and Safety Act, 21 U.S.C. Section 360hh et seq. (incorporated into the Food, Drug, and Cosmetic Act), and the regulations promulgated thereunder. The defendants imported into the United States and introduced into commerce two shipments of a total of 38 television receivers (Sony models 220-240v KPR-S53MN1/2 and 220-240V KPR-S46MN1/2), which did not comply with all applicable performance standards in that they did not bear a certificate of compliance as required by 21 U.S.C. Section 360kk(a)(1), 21 C.F.R. Section 1010.2(b) (1996), and 21 C.F.R. Section 1005.3 (1996)--538(a)(1). The defendants refused to permit Food and Drug Administration ("FDA") inspectors to have access to K & K's records, to enter onto K & K's premises, or to inspect K & K--538(a)(3). The defendants delivered television receivers to distributors or dealers without certifying that they conformed to all applicable performance standards, as required by 21 U.S.C. Section 360kk(h) and 21 C.F.R. Section 1010.2 (1994)--538(a)(5). Lastly, the defendants failed to submit reports required pursuant to 21 U.S.C. Section 360nn(b)--538(a)(4).
DISPOSITION: A default judgment against K & K was entered Sept. 11, 1997, enjoining it from: (a) importing into the United States any electronic products that do not comply with all applicable performance standards or that lack certification to that effect; (b) failing or refusing to permit FDA to inspect records that the defendants are required to establish and maintain, or make available such records for FDA inspection in accordance with 21 U.S.C. Section 360nn; (c) failing or refusing to file reports required by 21 U.S.C. Section 360nn(b) and 21 C.F.R. Sections 1002.10, 1002.11 and 1002.13; and (d) failing to furnish to the distributer or dealer at the time of delivery of electronic products, a certificate that the products conform to all applicable performance standards, in accordance with 21 U.S.C. Section 360kk(h). (Inj. 1383; S. No. 94-644-622; S.J. No. 12)

DEFENDANT: Mira, Inc., a corporation, and Luc J. Schepens and Roger R. O'Brien, individuals, at Waltham, Mass. (D. Mass.); Civil Action No. 95-10731.
CHARGED 4-7-95: While held for sale, after shipment of one or more of their components in interstate commerce, at Mira, Inc., in Waltham, Mass., articles of an ophthalmic device were adulterated in that the methods used in and the facilities and controls used for the manufacture, packing and storage of the Cryo probe and the Imex implant did not conform to and were not in conformity with good manufacturing practice regulations--501(h).
DISPOSITION: All articles of device in possession or control of the defendants, except those devices that were brought into compliance, were destroyed at the defendants' expense. (Inj. 1373; S. No. 94-658-563; S.J. No. 13)

DEFENDANT: Producer's Peanut Co., Inc., a corporation, and James R. Pond Sr., an individual, at Suffolk, Va. (E.D. Va.); Civil No. 2:95CV256.
CHARGED 3-15-95: On March 21, 1995, a consent decree of permanent injunction was entered against the defendant. This statutory injunction was brought to enjoin the defendants from the manufacturing, processing, packing, labeling, storing, and holding for sale of peanut butter, a food within the meaning of 21 U.S.C. Section 321(f), after one or more of its components had been shipped in interstate commerce, and from introducing and delivering for introduction into interstate commerce such peanut butter. This peanut butter manufacturer had a long history of violation involving sanitation. Past inspections revealed gross insanitary conditions, including insects in peanuts being processed into peanut butter, insects in and around peanut butter processing equipment, accumulations of product residue and static material on processing equipment, and ineffective cleaning and sanitation procedures. While held for sale after shipment of one or more of its components in interstate commerce at Producer's Peanut Company, Inc., in Suffolk, Va., all articles of food were adulterated in that they were prepared, packed and held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
In 1998, after an inspection had revealed relatively few inspectional observations, defense counsel sought to have the injunction lifted.
DISPOSITION: The Food and Drug Administration conducted another inspection, decided that the company was sufficiently in compliance, and a motion to vacate the permanent injunction was granted on March 5, 1999.
(Inj. 1376; S. No. 94-703-691; S.J. No. 14)

DEFENDANT: Henry H. Vechery, an individual, doing business as May's Seafood, and Joyce A. Krantz, an individual, at New Orleans, La. (E.D. La.); Civil Action No. 97-3873.
CHARGED 12-16-97: While held for sale after shipment in interstate commerce at May's Seafood, in New Orleans, La., the article of food (crab meat) was adulterated in that the crab meat had been prepared, packed or held under insanitary conditions whereby it might have become contaminated with filth--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was entered April 21, 1998, and under that decree, the defendants were enjoined from processing crab. The consent decree allowed the firm to continue to operate as a live crab receiving dock. (Inj. No. 1417; S. No. 96-763-647;
S.J. No. 15)

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