COMPANY'S FACILITY CONDITIONS CONTAMINATED PRODUCTS, FDA SAYS

Bell-More Laboratories failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.

During inspections Aug. 7-17, 2006, agency investigators found that Bell-More's finished products were adulterated because of current good manufacturing practice violations, according to the letter, which was sent Jan. 5 and posted to the FDA website Feb. 20.

The company responded twice to the Form 483; however, many responses to the violations lacked sufficient information, the FDA said. Because of the inadequate responses, the agency requested that company representatives present their corrective action plans at a meeting with FDA officials.

Bell-More's manufacturing and storage facilities lacked adequate building design, according to the letter. For example, there was a small hole at the junction of the ceiling and the wall of an entry room where a sprinkler head was mounted, the letter said. In addition, there were gaps between ceiling tiles. The inspectors also found a rust-like substance on metal frames around doors and on cabinets, the letter added.

A spokesman for the company declined to comment.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6225d.pdf ( http://www.fda.gov/foi/warning_letters/g6225d.pdf ).