In response to an FDA warning letter, a Brazilian drug manufacturer told the FDA it has no intention of producing over-the-counter drugs for the U.S. market.
Mappel Indústria de Embalagens of São Paulo, Brazil, said in response to an April FDA inspection of its facility that when it began manufacturing products for the U.S. market, “it did not fully comprehend that such products were regulated by the FDA as OTC drugs.”
In the response, which was included in an FDA warning letter recently published on the agency’s website, the company said “Mappel has no intention of manufacturing OTC drug products for (b)(4) and should it decide to do so (b)(4), it will notify the FDA by filing a new drug establishment registration.”
During its inspection that ran from April 11 to 15 earlier this year, agency inspectors cited the failure of the company’s quality-control unit, a lack of appropriate laboratory equipment to determine conformance of products to final specs before they are released to the U.S. market, and inadequate written procedures for production and process protocols.
If Mappel does wish to re-enter the OTC manufacturing market for the U.S., the FDA recommended that the company hire a consultant and correct all previous violations. In the meantime, the agency is unlikely to approve any new applications or supplements of products manufactured at the site and may refuse to allow the importation of such drugs.
Last month, the agency cited another Brazilian company, Lima & Pergher, with a warning letter after inspectors found significant violations at the company’s manufacturing facility.
- here’s the FDA warning letter
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