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Center for Drug Evaluation and Research cont. 2001

Chapter 3

Last Update: August 07, 2003

Seizure at Mueller Sports Medicine, Inc.
CGMP Problems Lead to Seizure of OTC Drugs

On February 15, 2001, FDA investigators from the Minneapolis District Office accompanied the U.S. Marshals Service in a seizure of Half and Half balm; Hot Stuff balm; Runners Lubricant; Muellergesic balm; and Sports balm, Abrasion Ointment; Foot and Body powder, at Mueller Sports Medicine, Inc., Prairie Du Sac, Wisconsin. The FDA had issued a Warning Letter to the firm August 6, 1999, and again on June 29, 2000, following an inspection on March 10, 2000. During the inspection, FDA investigators documented serious CGMP violations. The products and labels were seized due to CGMP violations, unapproved new drug charges and misbranding violations. On June 21, 2001, the district supervised the preparation for destruction of unapproved drug products and labels. The products will be incinerated.

On May 24, 2001, the judge for the Western District of Wisconsin entered a Consent Decree of Condemnation and Destruction. Under the Consent Decree, Mueller must destroy the seized goods under FDA's supervision and pay FDA's costs associated with such supervision. In addition, within 60 days after entry of the decree, Mueller must retain an outside expert to inspect the firm's facility and certify that the facility is in compliance with CGMP regulations. If the expert does not certify compliance within 90 days of the entry of the decree, or if Mueller doesn't submit the written report, Mueller must cease manufacture, processing, packing, holding and distribution of articles of drug. The decree also provides FDA with special inspection authority, letter shutdown authority, and the arbitrary and capricious standard of review.

FDA Witnesses Destruction of Drug Products
Drugs Held Under Uncontrolled Temperature Conditions Destroyed

On June 28, 2001, the FDA's San Juan District Office witnessed the destruction of 16 drums of Tylenol, 80 mg. Fruit Chewable Tablets manufactured by McNeil Consumer Healthcare, Las Piedras, Puerto Rico, valued at $13,873. The product arrived in San Juan on April 22, 2000, and stood unclaimed by its owner for over a year. FDA was contacted by U.S. Customs Service who was interested in auctioning the product. An investigation disclosed that the material had been shipped to Canada to undergo the packing process, but was returned intact because the packer was unable to complete the process before the product expiration date. Representatives of McNiel Consumer Healthcare decided to voluntarily destroy the product because it had been stored under uncontrolled temperature conditions.

Seizure at Gapardis Health and Beauty
Unapproved and Misbranded Foreign OTC Drugs and Cosmetic Products Seized

FDA Investigators accompanied the U.S. Marshals Service in the execution of a seizure and condemnation action at Gapardis Health and Beauty, Inc., Garfield, New Jersey. The seizure took place on October 2, 2001. The firm is a distributor of foreign OTC drug and cosmetic products. Twenty-four products, totaling 1,035 cases valued at approximately $63,466 were seized because they were misbranded and unapproved new drugs. The products had been embargoed by the New Jersey Department of Health and Senior Services on February 1, 2001, during a joint investigation of the facility by the FDA's New Jersey District Office, the Office of Criminal Investigations, the New York Field Office and New York District's Imports Operations Branch.

Seizure at York Pharmaceuticals, Inc.

On September 27 - 28, 2001, FDA investigators from the Kansas District Office accompanied by a U.S. Marshal, seized over $110,000 (estimated) of raw materials, in-process materials and finished product at York Pharmaceucials, Inc., Kansas City, Kansas. The firm is a manufacturer of generic aspirin, liquid antacids and anti-diarrheals, and topical antiseptic products. FDA issued a Warning Letter to the firm on April 24, 2000, detailing numerous CGMP deviations observed during an FDA inspection from March 20 - April 7, 2000. The seizure followed several violative inspections, which revealed continuing significant deviations from CGMPs. In addition, numerous products manufactured by York Pharmaceuticals, were recalled in 2001, due to superpotency, subpotency, and impurities.

Postmarketing Adverse Drug Experience Reports

Warning Issued for Delay in Reporting Adverse Drug Experience
FDA Inspection Discloses Late Submission of PADE Reports

On December 20, 2000, the Center for Drug Evaluation and Research issued a Warning Letter to the president and general manager of Organon Teknika BV, The Netherlands. The FDA conducted an inspection of the firm's facility in Boxtel, The Netherlands, on September 11 - 14, 2000. The inspection disclosed that the firm had failed to submit to FDA serious and unexpected adverse drug experience reports within 15 calendar days of the initial receipt of the information. The Warning Letter also noted that late reporting deviations from Postmarketing Adverse Drug Experience (PADE) regulations were disclosed during an inspection of an Organon, Inc., West Orange, New Jersey facility.

That inspection revealed that many of the foreign 15 day reports submitted late by Organon, Inc. New Jersey, had been submitted over 15 calendar days late to them by Organon facilities in Teknika BV and NV Organon, Oss. The Netherlands. Despite promised corrections, the most recent inspection revealed that five PADE reports were submitted significantly late to Organon, Inc. in New Jersey. One of the five reports, involving the death of an infant, was submitted to Organon, New Jersey, approximately 14 months after receipt by the firm.

Unapproved Drugs

Warning Issued for Unapproved Drug for Skin Disorders
OTC Product Found to Contain Undeclared Corticosteroids

On April 10, 2001, the FDA's Florida District Office issued a Warning Letter to Skintech 2000, Inc., Fort Lauderdale, Florida, for marketing a new drug without an approved NDA. An FDA inspection of the firm on December 5 and 15, 2000, found the firm marketing Blue Cap Spray, which was labeled and promoted for the relief of chronic skin disorders such as psoriasis, eczema, and dermatitis. The product contained undeclared corticosteroids, and the declared active ingredient, zinc pyrithione, which is not generally recognized as safe and effective for OTC use in treating psoriasis.

Warning Letter Issued for Anti-Fungal Liquid Therapy

The FDA's Florida District Office issued a Warning Letter on July 11, 2001, to Salon Sciences Corporation, Fort Lauderdale, Florida. The inspection on January 24, - 25, 2001, and 31, 2001, found that the firm was repacking, labeling, and distributing a product called "Fungi Septic Anti-Fungal Topical Liquid Therapy." Because there are no active ingredients recognized for over the counter treatment of fungal infections on the scalp and nails, the product is considered to be a new drug which may not be legally marketed in the U.S. without an approved new drug application.

FDA Assists Customs in Seizure of Unapproved Drugs

The FDA's New York District Office Import Operations participated in joint investigations with U.S. Customs at Newark International Airport concerning importations of unapproved drug products. A shipment of 30 varieties of injectable steroids imported from Germany by Brian Corwin, Longmeadow, Massachusetts, and four kilograms of ephedrine tablets imported from Mexico by Key International, Newark, New Jersey were detained and seized by Customs.

Unapproved Drugs Voluntarily Destroyed

The FDA's New Jersey District Office conducted an inspection of Castillo distributors, Inc., Little Ferry, New Jersey. The firm is a distributor of "Spanish Products," including drug products imported from the Dominican Republic. The inspection resulted in the firm's voluntary destruction of 11 unapproved or mislabeled drug products valued at approximately $11,387. These products included Penicillin G cream, Belladona pomade, Hemoglobin-containing beverages, Mercury-containing cream and soaps and a skin bleaching cream. The import documents for these products indicated the "Port of Discharge" and "Destination" as Newark, New Jersey. The documents declared the cargo as cosmetics but did not identify any drug products.

World Without Cancer, Inc. Permanently Enjoined
Firm Enjoined From Promoting Laetrile or Any Unapproved Drug

U.S. v. World Without Cancer, Inc., Health Genesis Corporation, The Health World International, Inc., and David E. Arjona (S.D. Fla.) Defendants enjoined from introducing into interstate commerce, holding, manufacturing, or distributing injectable amygdalin, amygdalin tablets, apricot seed, or any similar product containing or purporting to contain amygdalin, On December 1, 2000, a District Court Judge entered a Consent Decree and Order Relating to Defendant Health World International, Inc. ("Health World"). The decree permanently enjoins Health World, Laetrile, or Vitamin B-17 until an approved new drug application or an investigational new drug application is in effect for such drug product.

In addition, Health World is permanently enjoined from promoting, advertising, or representing, in conjunction with the sale, that the foregoing or similar products are safe and/or effective in the cure, mitigation, treatment, or prevention of any disease, unless and until an approved new drug application authorizing such representations is in effect for such drug product.

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