FDA Hits Massachusetts Drugmaker With 11-Item Form 483

The FDA has hit a sterile drugmaker with an 11-observation Form 483 for a host of sterility problems.

A Jan. 11 to Jan. 27 inspection of New England Home Therapies’ facility in Southborough, Mass., cited the company for eight sterility issues, two recordkeeping problems and one instance of potential product adulteration.

The inspector’s chief complaint was that employees working in clean rooms were not wearing appropriately sterile clothing, the 483 says. For example, employees working in one clean room were seen working in unsterilized gowns, while those entering another clean area failed to wash their hands prior.