Tag Archive for: FDA inspections

The FDA is planning to increase its inspection of drug manufacturing facilities in India this year amid growing quality and supply concerns, Reuters reported Tuesday citing an agency executive.

Concerned that the U.S. is becoming “overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations,” the House committee has launched its own investigation into the agency’s foreign drug inspection program.

Emergent BioSolutions Inc. said on Friday it had received a warning letter from the U.S. Food and Drug Administration, citing certain deficiencies at the contract drugmaker’s manufacturing facility in Baltimore, Maryland.

China-based drug developer BeiGene said on Thursday the U.S. Food and Drug Administration (FDA) has delayed a decision on its cancer drug as COVID-19 curbs in the country prevented the regulator from conducting inspections.