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The Food and Drug Administration (FDA) reiterates that transactions with the Agency should only be through official channels.

We have received a report from a concerned citizen that a certain “Johanna Cardona” is offering services to an establishment to process applications for Licenses to Operate (LTO) and Certificates of Product Registration (CPR) for a fee.

Notice is given to the public that no “Johanna Cardona” is currently employed under any of our offices, and therefore such person is not connected with the FDA.

It is reiterated that only Qualified Persons should be responsible for the regulatory affairs of regulated establishments. Caution is advised in dealing with entities claiming to expedite the issuance of market authorization applications with the FDA.

Dissemination of this advisory is hereby requested.