Inspections and Audits

FDA Guidances Part of Charm Offensive to Woo Compounders

The flurry of FDA guidance issued this week explaining to compounders how to work with the FDA is part of the agency’s full-on effort to make registration as appealing as possible to compounders who may worry that regulatory oversight will hamper business. Read More

Altaire Gets 483 for Mold in Eye Drop Drugs

The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL. Read More