PET Food Processing - September 2019 - 23

FOOD SAFETY

Navigating

FSMA
inspections

What we
already know,
and what
facilities
should be
ready for
during FSMA
inspections.

By Louise Calderwood | director of regulatory affairs, American Feed Industry Association

Inspections to review compliance with the Food Safety
Modernization Act (FSMA) are now a reality across the
animal food industry. With all compliance deadlines for
the two major types of FSMA inspections - Current
Good Manufacturing Practices (CGMP) and Hazard
Analysis and Preventive Controls (HA/PC) - passing
last September, facilities, with the exception of small
facilities, which are not expected to receive HA/PC inspections until after October, are undergoing or preparing for federal inspections.
The American Feed Industry Association (AFIA) has
been communicating with the US Food and Drug Administration's (FDA) Office of Regulatory Affairs to
learn how facilities are faring under federal and state
inspections. In addition, AFIA has received questions
from members regarding what is and is not required
during inspections.

Inspection data for FY19

In a meeting with the FDA, AFIA discovered that, as of
June 11, more than half of all planned CGMP inspections had occurred at feed and pet food manufacturing
facilities across the country since Oct. 1, 2018. This included 358 inspections, carried out by federal and state
inspectors, of the 621 total that are planned to take place
before the end of the fiscal year on Sept. 30.
During the same time period, a little less than onethird of all HA/PC inspections had taken place, with 63
conducted of 218 planned. Only two foreign supplier
verification program (FSVP) and roughly half of the
sanitary transportation inspections had been conducted.

The FDA staff told AFIA it is critical that facilities keep accurate records, maintain equipment and
buildings in a clean and orderly manner, and carry out
effective pest control programs. Most inspector questions
or concerns have fallen in these areas but, overall, the
FDA said inspections had been going well considering
the learning process for both state and federal inspectors on ensuring consistency in inspections, and for
facilities in balancing the inspections while maintaining
business operations.

Tips for FSMA inspections

AFIA members have been reaching out to the association's legislative and regulatory staff with questions on
what is expected during inspections, as well as providing
general feedback on how their inspections went in terms
of the questions asked, the areas the inspectors visited
and any discrepancies from regulatory guidance. This
information, which AFIA holds strictly confidential,
allows the association to communicate generally to its
members on the ways they can better ready their facilities
and their staff for upcoming inspections. The following
are a few reminders for pet food manufacturers:

Hazard analysis and following the plan

All animal food manufacturers must show they have
completed a hazard analysis and developed a written
animal food safety plan. According to the FDA, some
firms are lacking an explanation in their hazard analysis
on why something is not a hazard in their facility.
Inspectors have recently cited facilities for not having

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PET Food Processing - September 2019

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