Inspections and Audits

FDA Cites Supplement Company for Drug Claims

A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Read More

FDA Bugged by Conditions at Dallas Infusion Pharmacy

The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to store ingredients and finished products. Read More

Magellan Health Drugmaking Outlet Dinged by FDA

A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile processing procedures. Read More