Canadian API Maker Medisca Lands FDA Warning Letter for Mislabeling Products

The FDA issued a warning letter to Canadian API maker Medisca for mislabeling its products.

The Feb. 17 to 27, 2014, inspection was initiated because patients reported serious adverse events after taking compounded API labeled as L-Citrulline. Investigators tested six samples of the API and discovered that the drug’s strength differed from what the label purported, and that purity and quality fell below standards cited on the label.

Subsequent FDA laboratory analysis of the samples also determined that two of the samples were N-Acetyl-Leucine, a different amino acid, the warning letter said, which deemed the products misbranded.

Following the inspection, Medisca recalled eight lots of the L-Citrulline product after the company’s testing supported the FDA’s findings.

In its response, Medisca said it did not view L-Citrulline as an API, but the agency disagreed with that sentiment.

“Your firm repackaged, relabeled and distributed L-Citrulline to compounding pharmacies and hospitals that, you were informed, used this product as a bulk drug substance in compounding drugs,” the warning letter said.

Additionally, the company was repackaging and distributing the API domperidone to pharmacies for use in compounding drugs. The API is not a component of an FDA-approved drug, and therefore the company should stop repacking and distributing it immediately, the warning letter said.

Medisca did not return a request for comment by press time. 

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