Tag Archive for: warning letter

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.

In the letter dated Nov. 13, FDA said Amazon was selling eye drops which have not been recognized as safe and effective for providing temporary relief from eye symptoms such as excessive watery discharge, redness, burning, or pink eye.

FDA issued warning letters to Olympus’ units pertaining to a category of devices known as endoscopes, citing violations at its facilities.

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.