Barefoot Employees Earn Eye Drop Manufacturer an FDA Warning Letter

A drug manufacturing facility with ungowned, barefoot employees received an FDA Warning Letter that cited “insanitary conditions” in the production of sterile ophthalmic drug products, and was among the manufacturers cited in a recent FDA consumer warning on the risk of contaminated eye drops.

Kilitch Healthcare India Limited in Mumbai, is the recipient of the letter dated March 28, which followed an FDA inspection Oct. 12-20, 2023,and after which the FDA placed the company on an Import Alert, the letter states.

The company has suspended production of all drug products for the U.S. market, according to the letter and as of Nov. 15, 2023, had recalled affected products distributed in the U.S., but only after “numerous attempts by the Agency to obtain” a recall decision.

Read the Warning Letter here.

To read the whole story, click here.

Related Topics