Mappel doesn't want to supply US after warning letter

By Gareth Macdonald

- Last updated on GMT

Related tags Over-the-counter drug

Mappel doesn't want to supply US after warning letter
Mappel Indústria de Embalagens says it did not know the US would regulate the dermacosmetic products made at its Sao Paulo plant as OTC drugs after FDA warning.

The Brazilian manufacturer’s comments were part of its response to a US Food and Drug Administration (FDA) inspection in April, details of which were shared in a warning letter this week.

According to the FDA, Mappel “did not fully comprehend that such products were regulated by the FDA as OTC drugs​” and has said it has “has no intention of manufacturing OTC drug products​” for the US market.

Mappel states that the 4,300 square meter facility makes cosmetic and dermacosmetic products at the facility.

FDA inspectors who visited the facility in April raised a number of concerns about operations, including the failure of the quality control laboratory to assess products made at the site.

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