Dressing Maker Warned for cGMP, Supplier Quality Shortcomings

A host of violations related to current good manufacturing practices (cGMPs), including failure to adequately validate packaging and sterilization processes, has landed PhotoMedex — a Montgomeryville, Pa.-based maker of burn and wound dressings — an FDA warning letter. The Jan. 26 letter also cites a long list of deficiencies in the devicemaker’s procedures for submitting medical device reports (MDR).
Devices & Diagnostics Letter