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Warning letter given to Brazilian Over-The-Counter Drug Manufacturer

FDA has given a warning letter to Brazil’s Mappel Industria de Embalagens on account of GMP violations related to over-the-counter drugs. The inspection was held at Sao Paulo-based manufacturing facility from 11 April to 15 April.

Following violations were observed
• Failure to approve or reject all procedures or specifications impacting the identity, strength, quality and purity of the drug product.
• No 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.
• Failure to follow written procedures for production and process control.
• Failure to maintain production, control or distribution records associated with a batch of a drug for at least one year after the expiration date.

According to the company, it did not realize fully that the certain OTC products which it manufactures are regulated by FDA as the company mostly packages pharmaceutical, veterinarian and cosmetic products.

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 all violations are completely corrected and compliance with cGMP is confirmed, FDA may withhold approval of any new applications or supplements listing the firm as a drug product manufacturer.


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