To Our Valued Customers,
We would like to remind you that under FDA FSMA §102, foreign facilities will have to re-validate their registration beginning Oct/Dec 2012. This validation will be bi-annual. FSMA gives FDA new authority to suspend registration in case of non-compliance. Customized Brokers will be ready to provided assistance with these re-validations.
Under FSMA §105 FDA will establish standards for safe production & harvesting. This will apply to processed foods and raw fruits & vegetables and are intended to minimize risk of serious adverse health consequences
Under FSMA §107 FDA has authority to collect fees but while the fees are in effect as of January 1st 2012, FDA has not started to issue invoices. The US Registered Agent shall be responsible registered facility’s fees.
FDA will charge hourly fees for its employees’ time spent on:
1. Re-inspection of Imported Foods
2. Re-inspection of Food Facilities
Domestic: US$ 224/hour
Foreign: US$ 325/ho
Under FSMA §103 facilities must:
* Evaluate hazards & implement preventive controls
* Monitor performance and verify effectiveness of preventive controls
* Maintain records and written plan on hazards and preventive controls
FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. At this ration, by 2015 a total of 9600 foreign facilities will be inspected.
It is our recommendation that you take the time to understand which provisions of the FSMA affects your business directly and begin training your staff to understand new FDA requirements, the timeline for implementation and ensure full compliance with the portions of FSMA that apply to your business.
If you have any questions, please contact Customized Brokers at 305-471-8989.