The US regulator outlined concerns about PCP’s remediation plan in a warning letter this week, explaining that the firm's plan to address problems identified at the facility during an inspection last October lacks detail.
Foremost among the Food and Drug Administration’s (FDA) concerns are measures PCP introduced to ensure the drug-containing transdermal patch products it makes are checked before being released to customers.
“Your ongoing corrective actions included a final inspection form, work instructions, guidance documents, and checklists to assure quality approval before you release product to owners. You did not specify if you were going to test your product prior to release.”
The FDA said PCP must “describe your corrective action plan to assure satisfactory conformance to specifications for your active ingredients and drug products prior to release.”
The agency also called on PCP to provide a process validation plan for its transdermal patches. It pointed out that products tested during the inspection were found to be sub potent, which it said is an indication that validation procedures are inadequate.
PCP did not respond to a request for comment ahead of publication.