Drugs

FDA Warns 2 Ophthalmic Drug Companies

FDA says it inspected Delsam Pharma in Mamaroneck, NY, and EzriCare in Lakewood, NJ, after an agency inspection revealed violative conditions at Global Pharma Healthcare Private Limited, a contract manufacturing organization used to manufacture ophthalmic drugs for Delsam and EzriCare. FDA issued 2/13 Warning Letters to Delsam and EzriCare for their role in receiving and then distributing adulterated drugs provided by Global. The letters also say that both companies’ products are misbranded because they are not sterile.

In the Delsam letter, FDA says its testing of products made by Delsam confirmed that they were contaminated with microorganisms and thus are adulterated. Products made for Delsam by Global also were found to be adulterated.

FDA expresses concern about Delsam’s handling of product complaints. It acknowledges that the company inactivated its labeler code and discontinued drug listing submissions to FDA. The agency asks whether the firm intends to resume distributing drugs for the U.S. market in the future.

FDA says Delsam has yet to respond to the Global inspection observations.

FDA raises many of the Delsam issues in its letter to EzriCare, including expressing concern about misbranded and adulterated drugs and handling consumer complaints. FDA acknowledges the company’s commitment to cease production of all drugs. It notes that the company’s labeler code remains active with the agency and asks EzriCare to clarify whether it intends to resume distributing any drugs in the future.

Both companies were told to respond with a list of specific actions they have taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome