Inspections, Compliance, Enforcement, and Criminal Investigations
Massimo's Dallas, Inc. 11/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 23, 2012
UPS OVERNIGHT MAIL
Ali A Heidari, Owner and President
Massimo's Dallas, Inc.
2610 Maple Avenue
Dallas, Texas 75243
Dear Mr. Heidari:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing firm located at 7303 John W. Carpenter Freeway, Dallas, Texas 75247 on June 5-13, 2012. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice Regulations (CGMP) for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the ready-to-eat baked food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links on FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. All persons working in direct contact with food and food contact surfaces must conform to hygienic practices including washing of hands thoroughly and sanitizing as necessary to protect against contamination with undesirable microorganisms to comply with 21 CFR 110.10(b)(1) and (3).
However during the inspection:
• Employees were observed not washing and sanitizing their hands prior to starting work and before they were observed handling ready to-eat products such as rolls, breads and pastries. Employees were also observed handling trash cans and then handling dough without washing and sanitizing their hands.
• Employees were observed working in the pastry production area wearing personal clothing without protective outer garments, hairnets or other hair restraints while production was in progress.
2. You must maintain buildings, fixtures, and other physical facilities of the plant in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). However, the investigator observed the following during the inspection:
• The ceiling in the bread production room, bread oven room and pastry kitchen had peeling and flaking paint directly over uncovered ready-to eat bread and pastry products. In addition the peeling and flaking paint was observed over food contact surfaces or adjacent to food contact surfaces including on bread pans, on the ice machine next to ice scoop and on bulk containers.
• The ceiling was leaking rain water in at least four places in the bread oven room where ready-to-eat bread and pastry products are held uncovered while cooling; and in the bread production room and pastry kitchen where finished products are decorated, sliced and packaged.
Water stained ceiling tiles were observed the pastry kitchen directly above the pastry dough wooden production tables.
3. You must take effective measures to product against the inclusion of metal and extraneous material in food as required by 21 CFR 110.80(b)(8). However, your employees were observed using a chipped knife to cut dough in the pastry kitchen and bread production room, a broken and chipped metal scoop was observed being used to gather raw ingredients in the pastry kitchen, and the belt on the roll divider in the bread production room was observed to be missing several metal pins.
4. Your firm must take all reasonable precautions to ensure that production procedures do not contribute to contamination from any source as required by 21 CFR 110.80. However, during the inspection the investigator observed the following:
• Uncovered ready-to-eat beads, rolls, and buns were observed being transported through a doorway with plastic curtain dividers that directly contacted the food products.
• The table used to hold cut bread prior to packaging was observed to be unclean with food debris.
5. You must maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). However the investigator observed the following during the inspection:
• Bread production equipment such as roll dividers, dough rolling machines and bun slicer had dried build-up residues on their food contact surfaces.
• Employees in pastry kitchen were observed washing food contact equipment with soap and rinsing with clear water, without any sanitization step.
• Mixers in the bread production rooms were observed to have chipped paint. Also the (b)(4) mixer was observed with significant accumulation residue build-up. According to your employee, he cleans the equipment and utensils daily with just water using no detergent or sanitizer.
6. You must have backflow protection from piping systems that discharge waste water and sewage as required by 21 CFR 110.37(b)(5). Specifically, your ice machine in the bread production room has a drain line that extends down into the floor drain without protection by a backflow preventative device.
7. You are required to have adequately installed and maintained plumbing that provides adequate floor drainage as required by 21 CFR 110.37(b)(4). However, during the inspection, the investigator noticed malodorous stagnant water on the bread production room floor in the north east corner.
8. You must take effective measures to exclude pests in any area of the food plant as required by 21 CFR 110.35(c). However, the investigator observed numerous flies in the bread production room, bread oven room, and pastry kitchen where products were being manufactured. Live flies were observed on formed dough in the pastry kitchen during the inspection.
In addition, we are concerned that your firm is not handling in-process food in a manner that prevents it from being exposed to substances capable of causing harm if not disclosed in the product labeling. Specially, the potential for cross contamination of nut-containing products with products that do not contain nuts was observed. Both in-process products were manufactured and stored adjacent to each other prior to packaging.
We acknowledge that your firm made corrections to several of the FDA-483 items while the investigator was still at your facility, such as addressing the potential cross contamination issues; removal of peeling paint and repainting several areas; changing air filters; cleaning bakery equipment and repair of gaps around doors. We also acknowledge your Manager's commitments to correct other observations noted. However, these or similar observations were also noted during your firm's previous inspection conducted on January 5-26, 2011.
Your firm should implement a systematic approach to detect and address sanitation deviations at your facility to ensure compliance and correction.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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. You should include in your response documentation such as records, 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31 (a)(2)(B)).
FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Ronda Loyd-Jones, Compliance Officer at 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact: Ronda Loyd-Jones at 214-253-5242.
Reynaldo R. Rodriguez ;Jr.
Dallas District Director
cc: Mohammed F. Damrah, Manager
7303 John W. Carpenter Fwy
Dallas, Texas 75247