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Department
of Health and Human Services
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Public Health Service
Food and Drug Administration
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San Juan District
Compliance Branch
466 Fernandez Juncos Avenue
San Juan, Puerto Rico 00901-3223
Telephone: 787-474-9500
FAX: 787-729-6658
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September 14, 2004
WARNING LETTER
SJN-04-14
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ms. Elena Lopez
President/Owner
E. Franco & Co.
Calle Manuel Pirallo # 3
Mayaguez, Puerto Rico 00680
Dear: Ms. Lopez:
This letter is in reference to the
inspection of your facility located, at Calle Manuel Pirallo # 3, Mayaguez.
Puerto Rico 00680 on April 19 thru 22, 2004 by an Investigator from the U.S.
Food and Drug Administration.
During that inspection, copies of
your pastry product label and samples of your Guava Filled Rolls (Brazo Gitiano
con Guayaba) were obtained. An FDA-483, Inspectional Observations, was issued
and our investigator discussed the observations with you. This inspection documented
violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21,
Code of Federal Regulations (CFR). You can find the Act and FDA regulations
through links on FDA’s home page at www.fda.gov.
We have reviewed the inspectional
observations and your product labels and have identified numerous violations
of the Act and applicable regulations. These violations cause your products
to be adulterated or misbranded, as discussed below.
Manufacturing Practices
At the conclusion of the Inspection, you were issued Form FDA-483 which delineated
a number of significant insanitary conditions present at your facilities at
the time of the inspection. These conditions cause products manufactured in
your facility to be adulterated under Section 402(a)(4) of the Act in that they
have been prepared, packed, or held under insanitary conditions whereby they
may have become contaminated with filth, or may have been rendered injurious
to health. Objectionable conditions observed include the following:
- Failure to exclude pests from
the food plant [21 CFR 110.35(c)]. Specifically:
- Two live cockroaches were
observed in direct contact with the metal trays used to hold batter for
baking and cooling, which were previously prepared for the next day’s
production.
- Fifteen beetles were observed
inside one tray filled with white flour that was stored uncovered on a
shelf in the baking production area. Seven beetles were walking over the
flour.
- Approximately twenty-five
dead cockroaches were observed on the floor below the counters in the
production area.
- Four dead cockroaches were
observed in the baking and filling area.
- Five dead cockroaches were
observed on the floor of the pastry cooling, frosting and cutting area.
- Fifteen dead cockroaches
were observed on the floor of the wine and beverage storage area.
- Failure to hold foods that support
the growth of undesirable microorganisms in a manner that prevents the foods
from becoming adulterated [21 CFR 110.80(b)(3)]. Specifically:
- The refrigerator located
in the production area had an internal temperature reading of 50°F.
This refrigerator is used to store finished products such as rolls filled
with any of the following: Bavarian Creme, cream cheese, pineapple, or
any fruit filling combined with cream cheese. Refrigerators holding these
particular foods should be kept at or below 45 degrees [21 CFR 110.80(b)(3)(i)].
- Failure to store and dispose
of rubbish to minimize the potential for waste becoming an attractant and
harborage or breeding place for Rests [21 CFR 110.37(f)]. Specifically:
- An uncovered garbage disposal
area containing garbage bags, boxes, and old plastic, wooden, or metal
containers, was observed in the plant storage area.
- Approximately four dozen
empty and uncovered pails with old encrusted raw filling material were
stored in a wooden closet without a roof located between two storage freezers.
- Failure to provide adequate
screening or other protection against pests [21 CFR 110.20(b)(7)]. Specifically:
- The two doors in the baking
and filling areas that open to an unscreened exterior patio have a gap
between them of approximately two inches.
- The windows located in the
storage area and leading to the street do not have screens.
- The door in the storage area
that leads to the street had a gap between the door and the floor of approximately
5 feet wide and 4 inches high The door in the storage area that leads
to the street was found open during the first day of inspection
- Failure to store raw materials
under conditions that will protect against contamination and minimize deterioration
[21 CFR 110.80(a)(1)]. Specifically:
- On April 19, 2004, one kettle
containing guava filling, for use as an ingredient on April 20, 2004,
was observed partially uncovered in the baking and filling area.
- On April 19, 2004, two brown
paper bags, each containing approximately 20 lbs of white flour used as
an ingredient on April 20, 2004, were observed unlabeled and uncovered
in the baking and filling area.
- Failure to design and use equipment
so as to preclude the adulteration of food with lubricants and contaminants
[21 CFR 110.40(a)]. Specifically:
- Tubes, a pulley, and the seams of the mixer equipment were covered
with a lubricant and were located directly above an uncovered kettle containing
guava ingredient. The lubricant used is not food grade.
- Failure to take necessary precautions
to ensure persons working in direct contact with food, food contact surfaces,
and food packaging materials conform to hygienic practices to protect against
contamination of food [21 CFR 110.10(b)]. Specifically:
- [redacted] were observed
wearing jewelry, such as earrings and/or neck chains in the production
area.
- None of the employees in
the production area were wearing hair nets.
Color Additives
- Your Brazo Gitano with guava
filling that is made with a vanilla flavored batter is adulterated under section
402(c) of the Act because the lemon emulsion concentrate used in the batter
contains the ingredient FD&C Yellow No. 5, which is not declared on the
finished product label. You must specifically declare the presence of FD&C
Yellow No. 5 in the ingredient declaration on your product labels to comply
with Title 21 Code of Federal Regulations (21 CFR) section 74.705(d)(2). In
addition, the specific declaration of FD&C Yellow No. 5 is a condition
for safe use of the color additives in food products.
- Your Brazo Gitano with guava
filling is also misbranded under section 403(i)(2) because certified color
additives must be individually declared in the ingredient statement by their
common or usual names (e.g., FD&C Yellow No. 5, which is in the batter,
and FD&C No. 40, which is in the guava filling) (see 21 CFR 101.22(k)(1)).
Food Labeling
- Your Brazo Gitano with guava
filling is further misbranded under section 403(1)(2) of the Act, in that
the package fails to list the common or usual name of each ingredient. These
ingredients must be listed in descending order of predominance by weight on
either the principal display panel or the information panel as required by
21 CFR 101.4(a)(1). Specifically, none of the ingredients contained in the
filling are listed in the ingredient statement and not all of the ingredients
in the batter (e.g., the white vanilla flavor, lemon emulsion concentrate,
vegetable lard, butter and honey ingredients) are listed in the ingredient
statement. In addition, ingredients which themselves contain two or more ingredients
must also be declared in the ingredient statement, in accordance with 21 CFR
101.4(b)(2). For example, all of the sub-ingredients in the enriched flour,
butter, baking powder, and lemon emulsion concentrate must be listed in the
ingredient statement.
We also note that the ingredient
statement on the package lists as ingredients mantequilla, manteca vegetal and
Amarillo vegetal (translated by FDA into English as margarine, vegetable butter
and yellow vegetable, respectively); however, these ingredients are not described
in the product formulation
- Your Brazo Gitano with guava
filling is misbranded under section 403(k) of the Act in that the label fails
to declare the presence of the preservatives potassium benzoate and potassium
sorbate.
We note that you informed the investigator
who inspected your facility that the nutrition information is only provided
on your Brazo Gitano with guava filling rolls that are sold to [redacted] You
should be advised that all of your products that are intended for human-consumption
and offered for sale must bear nutrition information in accordance with section
403(q)(1) of the Act, unless an exemption is provided for the products (see
21 CFR 101.9(j)). Nutrition information must be presented on the label in one
of the formats described in 21 CFR 101.9(d).
We do not object to your method
of indicating the flavor and filling type of your Brazo Gitano rolls by marking
a box(es) on the side panels. However, please note that the ingredients contained
in each of the flavors of your Brazo Gitano rolls should also be clearly indicated
on the product label.
[See section 505.100 of FDA’s
Compliance Policy Guide 7102.01, which can be found at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg505-100.html]
For example, FDA considers it misleading
to use the same ingredient statement on your Brazo Gitano vanilla flavor with
guava filling and on your Brazo Gitano chocolate flavor with coconut filling.
You may wish to consider an alternative means of compliance with the ingredient
labeling requirements, such as the use of a sticker label that bears the ingredient
statement that corresponds to the roll flavor and filling type that is indicated
on the side panels of your product package. If you choose this course of action,
we remind you that the sticker label should adhere to the package and be placed
on the principal display panel or the information panel.
Please note that we have only reviewed
the labels for the Brazo Gitano rolls with guava filling. You must ensure that
the labels for all of your products meet the applicable labeling requirements.
Failure to promptly correct these
violations and prevent future violations may result in regulatory action without
further notice, such as seizure or injunction. As a food manufacturer, it is
your responsibility to ensure that your products meet all of the requirements
of the Act and the regulations.
We request a response in writing
within fifteen (15) working days of receipt of this letter of the specific steps
you have taken to correct the violations listed above, including an explanation
of each step being taken to prevent the recurrence of the violations. Your written
reply should be addressed to the Food and Drug Administration, Attention: Carlos
I. Medina, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, and Puerto
Rico 00901.
Sincerely,
/s
Donald J. Voeller
District Director
San Juan District
Enclosures
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