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Regulatory Focus™ > News Articles > FDA Warns Brazilian OTC Drug Manufacturer

FDA Warns Brazilian OTC Drug Manufacturer

Posted 04 October 2016 | By Zachary Brennan 

FDA Warns Brazilian OTC Drug Manufacturer

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA.

FDA’s inspection of the Sao Paulo-based manufacturing facility from 11 April to 15 April found the company:

  • failed to approve or reject all procedures or specifications impacting the identity, strength, quality and purity of the drug product.
  • cannot confirm satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to the release of each batch.
  • failed to follow written procedures for production and process control.
  • failed to maintain production, control or distribution records associated with a batch of a drug for at least one year after the expiration date.

In its response to FDA, Mappel, which mostly packages pharmaceutical, veterinarian and cosmetic products (and advertises its new manufacturing unit on its website), said that when it began manufacturing certain OTC products for the US market, “it did not fully comprehend that such products were regulated by the FDA as OTC drugs.”

The company added: “Mappel has no intention of manufacturing OTC drug products for [redacted] and should it decide to do so [redacted], it will notify the FDA by filing a new drug establishment registration.”

If Mappel decides to resume drug manufacturing for the US market, FDA recommends the firm engage with a consultant to meet good manufacturing practice (GMP) standards.

“Until you completely correct all violations and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer,” the letter says.

Warning Letter

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