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FDA Certification


Steps for getting the FDA Certification

Signing of the certification contract:

Once GlobalSTD has been selected by your organization to carry out the certification process, the contract must be signed by both parties.

Consulting Audit (Pre-Audit):

This audit is conducted as a preparation for a regulation audit and it is used internally. Besides complying with the federal regulations, a consulting audit also takes into consideration how the facilities fulfill the industry’s regulations and practices. *This event is optional and not regarded as official for the certification.

Regulatory Audit (Certification):

The purpose of the audit is to evaluate the level of compliance of the food-safety requirements of the FDA’s FSMA Act, as well as the fulfillment of the industry’s applicable practices and regulations.

This audit takes place at the organization’s production site and it consists of two independent stages:

  • Stage 1: On-site or off-site announced audit. It seeks to evaluate the organization’s degree of preparation to go through the second stage.
  • Stage 2: On-site unannounced audit. This audit is essential for the certification. It is verified that the organization meets the applicable federal food-safety requirements.

Issuance of the certificate

The certificate will be issued once the audit has been successfully completed and the evidence shows that the organization’s facilities meet the FDA’s FSMA Act food-safety requirements, and that it complies with the industry’s applicable practices and regulations. All non-conformities detected during the audit must be closed.
The certificate will be valid for 12 months as of the date of the certification decision.

Re-Certification Audit

The re-certification audit is conducted to verify the organization’s continuous compliance of the FSMA´s Act applicable food-safety requirements. This audit should take place no later than 12 months as of the date of the initial-certification decision.

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