The Food and Drug Administration announced that Cal-Test Diagnostics, Inc., of Chino, Calif., has signed a consent decree of permanent injunction in which it agreed to stop making and selling its in-vitro diagnostic test kits until it corrects long-standing manufacturing problems and receives the required approval from the FDA for each of its products. The company also agreed to destroy its inventory.
The consent decree was signed today by Judge Christina A. Snyder in U.S. District Court in Los Angeles.
Cal-Test, also known as Cal-Tech Diagnostics, Calteck Diagnostics, and Chem-Tech Diagnostics, makes and sells numerous types of in-vitro diagnostic test kits, including several types of HIV, hepatitis and pregnancy tests. Most have not been approved or cleared by FDA.
The company's products are sold to laboratories, medical facilities and distributors in the United States and overseas.
Over the past four years, Cal-Test has failed to comply with FDA's Current Good Manufacturing Practice and Quality Systems regulations and has sold its test kits without prior FDA approval or clearance. The manufacturing deficiencies affected Cal-Test's methods and controls used to manufacture, pack, and store the test kits and also impacted the performance of the products.
The California State Food and Drug Branch inspected the Cal-Test in 1996 and cited the firm for 30 significant deviations from FDA regulations. The firm promised to make corrections. FDA inspected the firm in February 1997 and found similar violations. During the inspection, FDA discovered that Cal-Test had received several complaints that its HIV and pregnancy tests were inaccurate. The firm had not investigated or followed up on the complaints.
As a result of the inspection, FDA issued Cal-Tech a warning letter in March 1997. The firm agreed to stop marketing all of its unapproved test kits and correct other violations.
In 1999, FDA inspected the firm again and found that
Cal-Test was still manufacturing and distributing test kits illegally and had made no effort to correct any of its other violations and deficiencies.
Under the consent decree, signed by Cal-Test and its top corporate executive Horng Liang Chen (a.k.a. Robert Chen), Cal-Test will destroy all of its inventory and stop marketing and distributing its products in the U.S. and overseas until all test kits have been approved or cleared by FDA and all manufacturing deficiencies have been corrected. FDA will supervise destruction of the inventory.
The corrections will be overseen by an outside expert, hired by Cal-Test, who will certify to the FDA that corrections have been made.
Cal-Test will be allowed to resume operations once FDA is satisfied that the company is in compliance with the law. An outside expert will conduct audit inspections of the firm at least twice a year for at least five years to assure that the firm remains in compliance.
Cal-Test will reimburse FDA for all costs related to supervision, inspections, record reviews, examinations and analyses conducted under the consent decree.