WARNING LETTER
Banjaras Inc
MARCS-CMS 589115 —
September 25, 2019
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Sunit Kaur
Recipient Title
President
Banjaras Inc
2707 Gallion Dr.
Sugar Land
,
TX
77479-1979
United States
Issuing Office:
Division of Southwest Imports
United States
September 24, 2019
WARNING
LETTER
Re:  CMS # 589115
Dear Ms. Kaur:
On August 21, 2017, the
Food
and
Drug
Administration
conducted
an
Foreign
Supplier Verification
Program
(FSVP) inspection
at
2702
Galion
Dr.,
Sugar
Land,
TX 77479-1979.
We also
conducted
an
inspection on
July
10, 2019.
This
inspection
was
conducted
to
determine compliance
with the
requirements
of section 805 of the
Federal
Food,
Drug
and
Cosmetic
Act
(FD&C
Act)
(21
U.S.C.
384a) and
the
Foreign
Supplier
Verification
Program
(FSVP) implementing
regulation in 21
CFR
part
1
subpart
L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA's FSVP web page at
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-
verification-programs-fsvp-importers-food-humans-and-animals
.
During the most
recent
inspection,
we found
that
you
were
not in
compliance with
the
requirements
of 21
CFR
part
1
subpart
L for
your
coriander and
garlic
and
Rasam
powders
from
foreign
supplier
(b)(4)
.,
your Kesar mango
pulp
from
foreign
supplier
(b)(4)
,
and
your
Suji
rusk
from
foreign
supplier
(b)(4)
.
Your
firm
did not
have FSVPs
for these products.
Because
of
these significant
violations,
you
are not in
compliance with
section
805
of
the
FD&C
Act.
At the
conclusion
of the
FSVP
inspection,
our
investigator
provided
you
with
Form
FDA
483a, FSVP
Observations.
However,
we
have not
received
your
response
to the
Form
FDA
483a.
Your significant
violations
are described
below:
You did not
develop
an
FSVP
as
required
by
section 805 of the
FD&C
Act
and
21
CFR
part
1 subpart
L.
Specifically,
your
firm
did not
develop
an
FSVP
for
each
of
the following foods:
Coriander with
garlic
manufactured
by
(b)(4)
(e.g.,
entry
#KM6-
3516695-2
line 21/3)
Rasam
powder manufactured
by
(b)(4)
(e.g., entry #
KM6-
3516695-2
line 101/1)
Kesar mango pulp manufactured
by
(b)(4)
(e.g.,
entry #KM6-3523053- 5 line 11/1)
Suji
rusk
manufactured
by
(b)(4)
(e.g.,
entry
#KM6-3523668-0
Line
91/2)
The above violations are not
intended
to be
an
all-inclusive
list of
violations
of the
FSVP
requirements.
It
is
your
responsibility to ensure
that
you
are in
compliance with
section
805 of the
FD&C
Act
and
implementing
FSVP
regulation
in 21
CFR
part
1
subpart
L.
You take prompt
action
to
correct
the above
violations.
If
you
do not promptly
correct
them,
we
may take
further
action.
For instance,
we
may
take
action
under
section 801(a)(3) of the
FD&C
Act
(21 U.S.C.
381(a)(3))
to
refuse admission
of
Coriander and
garlic
and
Rasam
powder
manufactured
by (b)(4); Kesar mango pulp manufactured by
(b)(4)
; Suji rusk manufactured by
(b)(4)
. We may place the foods on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP on Import Alert  # 99-41, at
https://www.accessdata.fda.gov/cms_ia/ialist.html
. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should
respond
in writing
within
fifteen
(15)
working
days
from
your
receipt
of this
letter.
Your
response
should
address
the
specific things
you
are doing to
correct
these
violations.
You
should
include
in
your
response
documentation
and
information
that
would
assist
us in
evaluating
your
corrections,
(e.g.,
documentation
of changes
you
made,
such
as
a copy of
your revised
FSVP,
records
to
demonstrate
implementation
of
your
FSVP,
and
any
additional
information
that
you
wish to supply
relevant
to
your
compliance with
the
FSVP
regulation.
If
you
believe
that
your products
are not in
violation
of the
FD&C
Act,
include
your
reasoning
and
any
supporting
information
for
our
consideration.
If
you
cannot complete
all
corrections
within
15
days,
you
should explain the
reason
for
your
delay
and
state when
you
will
correct
any
remaining
violations.
Please send
your
reply
to
Food
and
Drug
Administration,
Attention:
Rosa
Linda Santos,
Compliance
Officer,
Division
of
Southwest
Imports,
4040
N.
Central
Expressway,
Suite 300,
Dallas,
TX
75204.
If
you
have
any
questions
regarding
this
letter,
you
may
contact
CO
Santos
via
email
at
rosa.santos@fda.hhs.gov
.
Please reference
CMS #589115 on any documents or
records
you
provide to us
and/or within
the
subject
line of
any
email
correspondence
you
send to us.
Sincerely,
/S/
Todd Cato
District Director
Division of Southwest Imports
Content current as of:
02/25/2020
Regulated Product(s)
Food & Beverages