Drug manufacturer enjoined - Biocraft Laboratories Inc. ordered to stop making products

FDA Consumer, April, 1995 by John Henkel

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."

From 1978 to 1984, the firm's failure to have sufficient standard operating procedures, along with inadequate employee training and supervision, resulted in several marketed products being mislabeled. This prompted six recalls.

Between June 1984 and May 1993, FDA inspected four Biocraft manufacturing facilities more than 20 times and routinely found multiple GMP problems. On one occasion, investigators logged 26 trouble areas.

Among the deficiencies:

* Amoxicillin for oral suspension and other products failed potency tests.

* The company did not have in place an effective quality control unit for manufacturing and product testing.

* Investigations of failed or out-of-specification test results were inadequate or not conducted as required.

* Required written reports were missing or contained discrepancies.

In addition, the company conducted 21 recalls of products such as hydrocortisone cream, bacitracin ointment, and cephradine capsules between January 1985 and September 1993 because of problems with potency, stability, labeling, and homogeneity.

Over the years, FDA sent Biocraft numerous warning letters and regulatory letters informing the firm of its GMP violations. In each instance, the company promised to correct its problems.

By October 1993, the sheer volume of GMP deficiencies prompted FDA to take stronger measures. "Biocraft's problems were significant enough that [FDA's Newark office] recommended an injunction," says Mota. "The recommendation was approved, but the injunction never went to court because the firm signed a consent decree."

Under the consent decree, Biocraft is required to manufacture its products in conformance with GMP regulations and also must reimburse FDA for inspection time and laboratory analytical work.