Magazine article FDA Consumer

Drug Manufacturer Enjoined

Magazine article FDA Consumer

Drug Manufacturer Enjoined

Article excerpt

After repeated failures to comply with good manufacturing practice (GMP) regulations, one of the country's largest generic drug makers was ordered by a federal court to stop producing and distributing several of its antibiotic products, including its version of the commonly prescribed oral drug amoxicillin.

Harold Snyder, president of Fair Lawn, N.J.-based Biocraft Laboratories Inc., signed a consent decree last July 29 that enjoined his firm from manufacturing and distributing the products until outside experts certify the company is complying with federal regulations.

In addition to including Biocraft's three forms of amoxicillin (chewable tablets and oral suspension for veterinary and human use), the decree requires specific certifications for the company's versions of amiloride HCTZ, albuterol sulfate tablets, metoclopramide tablets, cephradine (for oral suspension and in capsule form), clindamycin, amitriptyline, ampicillin for oral suspension, cephalexin for oral suspension, disopyramide capsules, nystatin (oral suspension), and SMZ/TMP tablets.

In addition, the decree, ordered by Judge Alfred J. Lichner Jr. in the U.S. District Court for the District of New Jersey, establishes a schedule for Biocraft to submit certification that its dozens of other products conform to federal regulations. If the company fails to meet the schedule, or if FDA rejects any certification, Biocraft will have to stop making or distributing the product in question.

At press time, FDA had reinspected the company and had allowed Biocraft to resume production of amoxicillin for oral suspension (both human and veterinary use). "This is Biocraft's biggest product, and they were anxious to get it back on line," says Mercedes Mota, compliance officer in FDA's Newark district office. "So we worked with them and did an expedited review, which they passed. …

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