FDA Detection & Audit

Consultancy and Assistance

For FDA Inspections and Audits

FDA Audits on FSVP Compliance

The US importer of human food products into the States, (in our case, a foreign exporter’s American subsidiary company), is supposed to pass an FDA audit aimed to verify the compliance of its imported goods with the FSMA regulation called Foreign Supplier Verification Program (FSVP).

Bravo Compliance offers your US division all the technical assistance and e-tools indispensable to manage plans’ drafting and filing procedures required at any stage of your importation process. At the FSVP inspection stage, Bravo Compliance is the professional consultant qualified to certify your firm per compliance with the FSVP requirements.

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Professional consulting and technical assistance for FSVP Inspection (FDA Audit)

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FDA product detention

If any lots of products received with your shipment appear or result to be uncompliant with any FDA rules or statutes, the agency may detain such lots and issue the importer a Notice of FDA Action under the “Detained” designation. The latter must be also considered a Notice of Detention and Hearing. Therefore, a US importer confronting an FDA Notice of Detention needs an experienced consultant to represent and document the claim at the hearing and obtain the release of the detained lots.

BRAVO Compliance’s Legal Services have an 8-year documented background to outline a top-level performance in getting detained shipments released by the FDA. In all these past 8 years, none of the large, medium, or small-sized US importers assisted by BRAVO Compliance has ever experienced a total loss of detained

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Legal services for FDA Notice of Detention

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FDA inspections – warning letters

The FDA issues a Warning Letter when an inspection at the importer’s facilities ascertains violations of regulatory significance in whatever import operations. A Warning Letter is the first-and-last attempt of the agency to achieve the importer’s prompt revision of its compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA). At this stage, it may be still considered an importer-friendly offer of penalties settlement and acquaintance by the FDA’s side. However, ignoring the aforesaid warning may most probably lead the US importer to a shipment total loss.  

BRAVO Compliance – Legal Consultancy Services can assist you throughout the FDA inspections and hearings in three ways of action: Informing and consulting your US division on any possible risks and chances implied in any defensive guidelines applicable to your specific case; providing the FDA with a legal response letter on the matter of agency’s objections (483’s), so as to help your US importer firm to close out the Warning Letter proceeding in question.

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Legal Assistance for FDA Inspections & Warning Letters

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Import alerts

Import alerts inform the FDA’s field staff and the community of distributors, sellers, and consumers that the agency has enough evidence to allow the so-called Detention Without Physical Examination (DWPE) for certain products that appear to be in violation of the FDA rules and regulations.

Bravo Compliance can get your merchandise promptly off detention and assist you in any cases of FDA Import Alerts. We will accompany you step by step, from corrective action and entries management, to petition and Agency advocacy.

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Legal Assistance for FDA Import Alerts

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USDA permits & On-hold shipments

The USDA exam is the US government’s cornerstone check to ensure the safeguarding of marketable food products from pests and other insect infestation. All goods imported into the US are supposed to rigorously fall into their respective safe-packing standards. Particular attention must be paid to products shipped in wooden packages, since sizeable or otherwise fineable in case of wrong packing.

Bravo Compliance can help you get all USDA permits and overcome Customs blocks of products due to lack of relevant permit.

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Professional Assistance with USDA Permits & On-Hold Shipment

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FDA PCHF inspection

At a certain step of the compliance procedure on Preventive Controls for Human Food (PCHF), which is part of the FSMA regulations, your American division, as a US importer of foreign food products into the US, is supposed to pass an FDA audit aimed to verify the firm’s compliance with the aforesaid PCHF rules.

Bravo Compliance can provide your firm with all the information and e-tools needed to manage the administrative formalities required case by case, in all the stages of your importation process. At this stage, Bravo Compliance acts as your qualified representative in the context of FDA audits on PCHF regulation compliance.

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Professional Assistance for PCHF Inspection (FDA Audit)

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