US FDA slams delivery patch firm Pocono Coated Products over sub-potent meds

By Gareth Macdonald

- Last updated on GMT

iStock/robertiez
iStock/robertiez

Related tags Pharmacology

The US FDA has criticized Pocono Coated Products' (PCP) efforts to bring its transdermal patch plant in Cherryville, North Carolina into compliance with cGMP standards.

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​.”

Sub-potent patches

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.

Related news

Show more

Related products

show more

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Product Brochure

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Related suppliers

Follow us

Products

View more

Webinars