November 18, 2005

The FDA has issued a warning letter to Minnesota-based OTC drugmaker Diversified Manufacturing, accusing the company of violating current good manufacturing practices (cGMPs).

The agency conducted an inspection of the firm's Newport, Minn., manufacturing facility in March, during which time the FDA's investigators found "significant deviations from cGMP regulations," according to the letter, which was posted to the FDA's website. Among the major violations:

Failure to validate cleaning of the equipment and to maintain records of maintenance, cleaning, sanitizing and inspection of the equipment. The FDA found no assurance that Diversified's mixing vessels used for industrial chemicals were not also used in the production of drugs because the mixing vessels were not dedicated and cleaning records were not maintained.

Failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, prior to release. The inspection revealed finished drug products were never tested for identity and strength prior to their release and distribution.

Failure to withhold from use each lot of components, drug product containers and closures until the lot has been sampled, tested, examined and released by the quality control unit. Diversified did not complete any raw material testing for any materials received, the FDA said, adding the company did not conduct a specific identity test on components and had also not verified its supplier's Certificate of Analysis.

To view the warning letter, go to http://www.fda.gov/foi/warning_letters/g5567d.pdf.