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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tropical Bakery Wholesale

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770
 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-11-01
October 5, 2010
 

Mr. Harold Mir
Tropical Bakery Wholesale
2460 West 1st Avenue
Hialeah, FL 33010

Dear Mr. Harold Mir:

The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 2460 W. 1st Ave, Hialeah, Florida, from May 26, 2010 to June 3, 2010, and found that you have serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that a variety of bread products prepared or stored at your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] because these bread products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have become injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:

1. Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food as required by 21 CFR 110.35(c).

Specifically, our investigator observed the following:

• A live fly sitting on the bread dough during processing.
• A live roach by the open bay door in the oven room.
• Approximately 10 flies sitting on the bread dough and the equipment in the processing room.
• A dead fly on a piece of finished bread in cooler #1.
• Approximately 6 flies in the oven room and approximately 2 other flies sitting on unpackaged finished bread.
• A live bird flying through the processing area that ate bread dough at two different times during production.

2. Your firm failed to properly store equipment and remove litter that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures as required by 21 CFR 110.20(a)(1).

Specifically, our investigator observed the following:

• A pile of discarded boxes and bags accumulated on the floor in the comer of freeze (b)(4)
• Accumulated debris and cluttered equipment located near the dumpster.

3. Your firm also failed to provide, where necessary, adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7).

Specifically, our investigator observed the following:

• Gaps between the floor and the door leading to the outside in proofer (b)(4) and in the bay door of the processing room.
• The bay door in the oven room was open during production.
• A screen door by the coolers was open during production.

4. Your firm failed to take necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin as required by 21 CFR 110.10(b)(9).

Specifically, our investigator observed the following:

• An employee's forearms and shirt, which appeared covered in perspiration, came into direct contact with bread dough.
• An employee touched dirty equipment and then touched bread dough without washing his hands.
• An employee placed bread dough onto a rolling cart with rusted legs. As he put the dough on the cart, the dough hung over and was in direct contact with the cart's legs.
• An employee dropped his knife on the floor and then used it to separate bread as it was coming out of the oven without sanitizing the knife.
• An employee cut the bread dough with the same knife he used to open a box of lard.
• An employee placed a bag of sugar and wrapped packs of yeast into the mixer before opening them to empty them into the mixer.
• An employee picked up an empty bucket from the floor and placed the bottom of the bucket in direct contact with the ice in the large ice bin used during processing without proper sanitation.
• An employee washed his hands without using soap and then handled bread dough.
• What appeared to be mold accumulating on the walls and ceilings of proofer (b)(4) and the ice storage container.
• Cigarette butts located on the floor of cooler (b)(4) next to a metal rolling cart containing finished bread products, in proofer (b)(4) next to a metal rolling cart with unfinished bread products, and in the drain cover by the three compartment sink.
• Various food products including finished bread waiting for distribution were in direct contact with the floor.
• The ice scoop handle was in direct contact with the ice.
• Several unlabeled bottles and containers stored in the processing area.

5. Your firm failed to ensure personnel remove all unsecured jewelry and other objects that might fall into food, equipment, or containers, and remove hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials as required by CFR 110.10(b)(4).

Specifically, our investigator observed the following:

• An employee wearing a watch and a bracelet while handling dough.
• An employee wearing earrings, a watch, and a ring while cutting and packaging finished bread.

6. Your firm failed to store raw materials and other ingredients in a segregated manner or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration as required by 21 CFR 110.80(a)(1).

Specifically, our investigator observed the following:

• Rodent bait adjacent to a pallet of salt in the raw material storage room.

7. Your plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned, kept clean, and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact as required by 21 CFR 110.20(b)(4).

Specifically, our investigator observed the following:

• Both air units in proofer (b)(4) were leaking.
• Drops of condensate formed above the uncovered bread products stored on the metal carts located in proofer (b)(4)

8. Your firm failed to maintain your buildings, fixtures, and other physical facilities of the plant in a sanitary condition and in repair sufficient to prevent food from becoming adulterated within the meaning of the act as required by 21 CFR 110.35(a).

Specifically, our investigator observed the following:

• Peeling paint on the ceiling directly above uncovered, unfinished product and peeling paint on the walls in both proofers (b)(4) and (b)(4)
• The roof in the raw material storage room was leaking.

9. Your firm failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food as required by CFR 110.20(b)(1).

Specifically, our investigator observed the following:

• Various metal carts containing unfinished bread products, finished bread products, and packing material in direct contact with the walls of the proofers, coolers, freezers, and ambient storage areas that they were stored in.

10. In addition your firm failed to remove personal belongings that are stored in an area where food is exposed as required by 21 CFR 110.10(b)(7).

Specifically, our investigator observed the following:

• A bicycle stored next to the entrance of cooler (b)(4) and adjacent to several metal rolling carts containing finished bread that was cooling.
• A gallon of personal water stored in the ice storage container.

11. Your firm failed to provide hand-washing facilities that are adequate and convenient and provide for a sanitary towel service or suitable drying devices as required by 21 CFR 110.37(e)(3).

Specifically, our investigator observed the following:

• A lack of sanitary towel service or suitable hand drying devices next to sinks located by the freezer, proofer, and in the men's and women's bathrooms.

You should take prompt action to correct the violations cited in this letter. Failure to correct these violations may result in enforcement action being initiated by the FDA without further notice. The Act provides for the seizure of violative products, the assessment of civil money penalties and for enjoining the manufacturer and/or distributor of violative products.

This letter is not intended to be an all-inclusive list of the violations at your bakery. It is your responsibility to ensure that you operate your bakery in compliance with the Act and FDA's regulations, including the CGMP regulations (21 CFR Part 110) and food labeling regulations (21 CFR Part 101).

FDA acknowledges your voluntary recall of your Pan Bolo, Midnight and Pan Picado breads, initiated during the inspection for the undeclared wheat flour contained in these breads. During the inspection you indicated you would correct the labeling of these products within 60 days of the inspection.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Additionally, your response should include documentation such as copies of the new labels for the products that your firm manufactures, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland FL 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris (407) 475-4730.
 

Sincerely,
/S/
Emma R. Singleton
Director, Florida District
 

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