Transdermal patch maker gets FDA warning letter for subpotent product

FDA
Pocono Coated Products has received an FDA warning letter for faulty testing that led it to sell subpotent transdermal pain patches.

A North Carolina company that makes transdermal patches—as well as construction flashing tapes and a custom coating system for body armor—has gotten slapped on the wrist by the FDA for poor product testing which resulted in it releasing patches that were subpotent.

The FDA this week posted a warning letter that was sent to the Pocono Coated Products plant in Cherryville, North Carolina, after an inspection last year found problems with its processes. According to the letter, a customer of Pocono recalled all of the patches it got from the company after they determined that they might not meet release standards.

The FDA did not identify the customer, but there was a recall earlier this year of the Renovo Patch distributed by TMIG of Marietta, Georgia, after the FDA found the pain patch containing capsaicin and menthol was unapproved and also subpotent. The label of the patch indicated it was manufactured by Pocono.

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The FDA faulted Pocono for releasing products without conducting or reviewing release testing to determine if the patches met the specifications. It said the company was not validating each step of its manufacturing process to see if products met specs.

“FDA test results demonstrating that your product was subpotent indicate that your un-validated manufacturing process is not capable of consistently delivering products that meet their specifications,” the letter said.

The FDA “strongly” recommended the company hire a consultant to help get its processes and testing in order. 

 

 

 

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