Inspections

OUR CONTRIBUTOR
Stephen Joseph
stephen@joysqms.comJoys Quality Management Systems

FSMA provides FDA with important new tools for inspection and compliance.

  • Mandated inspection frequency: The 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.
  • Records access: 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.
  • Testing by accredited laboratories: The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards. (Establishment of accreditation program due 2 years after enactment)
  • FDA: Inspection and Compliance

Guidance for Industry April 2014: What records must be established and maintained by non-transporters of food?

For non-transporters (i.e., persons who own food or who hold, manufacture, process, pack, import, receive, or distribute food for purposes other than transportation), the records have to:

1. Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including:

  • The name of the firm; address; telephone number; fax number and e-mail address, if available;
  • Type of food, including brand name and specific variety (e.g., Brand X cheddar cheese, not just cheese; romaine lettuce, not just lettuce);
  • Date received;
  • Quantity and type of packaging (e.g., 12 oz. bottles);
  • Identify the immediate transporter previous sources, including the name, address, telephone number – and, if available, fax number and e-mail address. Persons who manufacture, process, or pack food also must include lot or code number or other identifier, if the information exists.

2. Identify the immediate non-transporter subsequent recipients of all foods released, including:

  • The name of the firm; address; telephone number; fax number and e-mail address, if available;
  • Type of food, including brand name and specific variety;
  • Date released;
  • Quantity and type of packaging;
  • Identify the immediate transporter subsequent recipients, including the name, address, telephone number – and, if available, fax number and e-mail address. Persons who manufacture, process, or pack food also must include lot or code number or other identifier, if the information exists.
  • Information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.
  • FDA: Guidance to Industry Establishment and Maintenance of Records

Helpful Compliance Links

Stephen Joseph PowerPoint from FSMA Workshop 9/2015 FDA Inspections PP Document Icon

Sharing is Caring:

Quality Leaders is sponsored by MEIRxRS’s