maries every year, providing information about the number of Form 483s
issued to companies producing drugs,
foods, veterinary medicines, biologics,
medical devices, etc. A total of 5,045
Form 483s were issued from October
1, 2016, to September 30, 2017, out of
which 2,662 were issued to food companies. One hundred eight Form 483s
were issued against 21 C.F.R. 1.502(a) to
importers for not developing an FSVP
plan. It is already one of the top 20 violations in the food sector. Although the
first compliance date for implementing
the FSVP was May 30, 2017, it is interesting to note that FDA inspectors have
already issued 108 Form 483s to importers out of a total of some 300 importers
inspected in 6 months. It is quite likely
that FDA in 2018 will ramp up the
inspections of importers three to four
times that of last year.
The second compliance date was
March 19, 2018, for “small businesses”
(foreign suppliers with < 500 full-time
employees) and March 18, 2019, for
“qualified facilities” and “very small
businesses” (foreign suppliers with <
$1 million in average annual sales). The
compliance dates for importers whose
foreign suppliers are subject only to the
Produce Safety rule are July 29, 2019,
for small business and July 27, 2020, for
very small businesses. All other businesses must comply starting July 26,
2018. FSVP compliance dates are based
on the size of the foreign supplier and
not on the size of the U.S. importer.
Recent FDA FSVP Guidance
Documents
Recently, FDA has released the fol-
lowing FSVP draft guidance documents:
Application of the FSVP Regulation to the
Importation of Live Animals: Guidance for
Industry, March 2018
This guidance document provides
clarification regarding the applicability
of the FSVP rule for the importation of
live animals. The food resulting from
the slaughter and processing of certain
live animals cannot be consumed with-
out slaughter and processing at estab-
on-site auditing, sampling and testing, review of supplier records, and other ap-
propriate measures. Annual on-site audits of the supplier’s facility are required only
when there is a reasonable probability that exposure to a food hazard controlled by
the foreign supplier will result in a SAHCODHA hazard. However, the importer
may choose other means of comparable verification to confirm the foreign supplier
is producing the food in accordance with applicable U.S. safety standards.
As a result of the verification activities conducted by your QI, you may discover
that your foreign supplier is not properly
controlling the identified hazards. Should
this happen, you are required to take action
to correct the deficiency. The QI may be required to reevaluate the FSVP for the specific
food and foreign supplier, depending on the
deviations, and document them.
Reevaluation of your FSVP by your QI is
required every 3 years or anytime you become
aware of new information that may affect
your prior evaluations.
FDA is going to rely heavily on records
during inspections to determine your compliance with FSVP requirements. Therefore, ensure that your record maintenance procedures
are robust. Failure to keep adequate records is
a violation of the FSVP rule and the FD&C
Act. FDA can take enforcement action in such
cases. The list of records to be maintained
includes the Hazard Analysis, the foreign supplier performance evaluation, procedures for
approving foreign suppliers, foreign supplier
approvals, procedures to ensure use of only
approved foreign suppliers, determination
and frequency of verification activities, performance of verification activities, corrective actions, and reevaluations of your FSVP.
Records can be kept as original records, true copies, or electronic records.
Step 4: Determine applicability of other food safety requirements
Your foreign supplier may not be aware of the applicable U.S. food safety regulations. Your QI should determine whether other U.S. regulations apply to products
that are imported. You should communicate such requirements to your foreign supplier so that the foreign supplier is in a position to comply with these requirements
before the product reaches the U.S. port.
Step 5: Communicate effectively
The importance of communicating with your stakeholders cannot be overlooked.
You must ensure effective communication at all levels in the supply chain, including
your foreign suppliers, your clients/customers, and regulatory bodies. A good communication plan is all that is needed for effective communication.
Step 6: Be “FDA inspection ready”
This is the last step of the six-step approach to implementing a robust FSVP. It
will automatically fall into place once you have taken care of the five previous steps.
Implementation of FSVP Rules and FDA Inspections
The Office of Regulatory Affairs of FDA releases inspectional observational sum-
The Foreign Supplier Verification Program
“To proactively
mitigate or eliminate
the hazards in
imported foods, an
importer is required
to identify and
evaluate the known
or reasonably
foreseeable hazards
for each type of
food…”
