FDA: Drug Storage Conditions Among Top Issues in Recalls

Manufacturers that don’t negotiate quality agreements with wholesalers to ensure safe storage of their products may be risking recalls. “Looking at our recall data, I was surprised to see that one of the top issues is inadequate storage conditions” for drugs, Rosa Motta, FDA compliance officer, said at the Parenteral Drug Association 2010 Pharmaceutical Cold Chain Management Conference. The FDA also is seeing a trend in warning letter citations for violations of 21 CFR 211.166, which requires a written testing program to assess the stability characteristics of drugs.
Washington Drug Letter