Inspections and Audits

FDA Warns Indian API Maker For Blending Batches

The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More

ISPE Launches Quality Metrics Pilot Program

The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More

Another Indian Company Warned For Extensive Quality Problems

The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of active pharmaceutical ingredient with conforming batches. Read More

Two Compounders Warned for Mixing Unapproved Drugs

The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More

Hamburg: Global Regulatory Authority in the Works

To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities, Commissioner Margaret Hamburg says. Read More