Inspections, Compliance, Enforcement, and Criminal Investigations
PROLAC, INC. 1/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
January 12, 2011
Return Receipt Requested
Mr. Rafael G. De Corral
President and Owner
Calle Oeste 2 # 15
Bayamon, PR 00961
Dear Mr. De Corral:
The Food and Drug Administration (FDA) inspected Prolac Inc., your food manufacturing facility, located at Calle Oeste 2 # 15, Bayamon, Puerto Rico, from August 19 to September 9, 2010. Our investigation found serious violations of the Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] 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.
Further, during the inspection, our investigator collected labels for your food products. Our review of the labels and other evidence collected during the inspection indicate that your firm's Queso Del Pais Tridas Reseta Original (Tridas Original Recipe Cheese), Queso del Pais Tridas, Pasta y Queso Guayaba, (Tridas Guava Paste and Cheese), and Queso Del Pais Tridas, Pasta y Queso Mango (Tridas Mango Paste and Cheese) products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343]. You may find the Act and FDA regulations in the CFR through links in FDA's website at http://www.fda.gov.
1. To comply with 21 CFR 110.80, you must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source. However, the following violations were observed during manufacturing and packaging operations at your facility:
a) A filter funnel was placed on the floor of your facility in contact with a puddle of liquid. The same funnel was used to collect cheese curd and drain the curd into a transfer bin.
b) Excess cheese curd from the cheese molding process was collected in a bucket located on the floor under a table. The floor around the bucket was wet and the collected curd was exposed to splashes of liquid from the floor. The curd from the bucket was stored for reuse in the next manufacturing process.
c) The cheese cutting table was placed next to a hand and utensil wash station. Employees did not take precautions to protect the cheese being packed from potential contamination by splash or mist generated by the washing process.
2. To comply with 21 CFR 110.10(b), all persons working in direct contact with food, food contact surfaces, and food packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. However, our investigator observed:
a) Employees entering and cleaning the formulation and pasteurized milk tanks without changing or sanitizing the rubber boots, plastic apron, and hair restraints that they wore during manufacturing operations. Employees were observed wearing the same items while using the bathroom and when leaving the manufacturing area.
b) An employee cleaning plastic gloves covered with curd in the chlorine compartment prior to resuming the cheese molding operation. Gloves that are soiled should be cleaned with soap and water first to rid them of all food debris before putting them in the sanitizer solution.
c) An employee handling and placing the cheese blocks in the slicing machine without washing his hands or changing gloves after touching non-food contact surfaces. These non-food contact surfaces included the molds transport cart, the walking-cooler door, and the packaging area access door curtain.
3. To comply with 21 CFR 110.35(c), you must take effective measures to exclude pests from the processing areas. However, mosquitoes and small insects were observed flying in areas where product was exposed. There were also ants observed on the bottom of the window frame in the packaging area. Dead cockroaches were observed on the walk-in cooler floor and next to a wooden storage pallet. Additionally, there were flies observed in the raw materials receipt and storage area.
4. To comply with 21 CFR 110.35(a), you must maintain buildings, fixtures, or other physical facilities in a sanitary condition. However, the following were observed:
a) Damaged ceiling tiles throughout the production area, including directly over exposed products.
b) Standing water and other liquids on the floor of the production area, as well as drains without grids.
c) A leaking drain pipe located underneath of the three-compartment sink of the formulation room. Water leaks were also observed in the knee handle of the hand washing stations located in the formulation and pasteurization/cheese molding rooms.
5. To comply with 21 CFR 110.37 (b)(3), your plumbing must be of adequate design and adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment, or utensils. Additionally, to comply with 21 CFR 110.37(b)(5) you must provide that there is no backflow from or cross contamination between, piping systems that discharge waste water or sewage and systems that carry water for food or food manufacturing. However, a garden hose used to fill the formulation tanks during the cleaning process was attached to a water point of use not equipped with a backflow prevention device. A backflow prevention device was also not placed at the packaging area water use point that had a garden hose attached.
6. To comply with 21 CFR 110.35(b)(2), you must store toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials. However, a liquid cleaning compound was stored on the bottom shelf of the cheese cutting table in the packing room. Also, a liquid cleaning compound bottle was left above the right lid of the formulation tank. The storage of these compounds on and adjacent to food contact surfaces may cause those surfaces to become contaminated.
7. To comply with 21 CFR 110.37(a), you must provide running water at a suitable temperature for cleaning of equipment, utensils and food-packaging materials, and employee sanitary facilities. However, The three compartment sink used to clean equipment and utensils and the hand wash stations located in the formulation, pasteurization/cheese molding, and packaging areas lacked hot water.
8. To comply with 21 CFR 110.37(e), hand-washing facilities must be adequate and convenient and be furnished with running water at a suitable temperature. However, your firm failed to provide hot water in the bathroom facilities.
10. To comply with 21 CFR 110.20(b)(7), you must provide, where necessary, adequate screening or other protection against pests. However, during our inspection, the entrance to your firm’s interior remained open during regular operations. The plastic curtain door that allows access to the raw material storage was not completely closed, and this door and the exhaust fan lacked a screen. There were gaps in the plastic door that is at the entrance to the cheese packaging room, and the door located in the formulation room had a ¾ inch gap. These may serve as an entry way for pests.
1. Your Tridas Receta Original (Tridas Original Recipe Cheese), Tridas Pasta y Queso “Guayaba” (Tridas Guava Paste and Cheese), and Tridas Pasta y Queso “Mango” (Tridas Mango Paste and Cheese) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels fail to declare the common or usual name of each ingredient as required by 21 CFR 101.4(a)(1). The ingredient statements for your Tridas Receta Original (Tridas Original Recipe Cheese), Tridas Pasta y Queso “Guayaba” (Tridas Guava Paste and Cheese), and Tridas Pasta y Queso “Mango” (Tridas Mango Paste and Cheese) products declare “proteina concentrada de leche” (milk protein concentrate); however, the statements fail to list the ingredient water in any of the cheese products. During the inspection of your firm, the FDA investigator noted the reconstitution procedures for the milk protein concentrate in these products consisted of (b)(4).
2. Your Tridas Receta Original (Tridas Original Recipe Cheese), Tridas Pasta y Queso “Guayaba” (Tridas Guava Paste and Cheese), and Tridas Pasta y Queso “Mango” (Tridas Mango Paste and Cheese) products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that their labeling is false or misleading because their ingredient statements do not accurately represent the ingredients used in these products. The labels list “Leche de vaca fresca y/o proteina concentrada de leche y crema fresca” (fresh cow’s milk and/or protein concentrate from milk and fresh cream) as ingredients; however your product formulation for these products does not include the use of milk in its manufacture. In addition, you can not use “y/o” (and/or) for these ingredients. The ingredient statement must provide an accurate list of only the ingredients that are used in the product’s manufacture listed by their common or usual name.
3. Your Tridas Receta Original (Tridas Original Recipe Cheese), Tridas Pasta y Queso “Guayaba” (Tridas Guava Paste and Cheese) and Tridas Pasta y Queso “Mango” (Tridas Mango Paste and Cheese) are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Specifically,
• The amount of trans fat is not declared [21 CFR 101.9(c)(2)(ii)];
• The number of Servings Per Container is not declared [21 CFR 101.9(b)(8)];
• The Total Calories are not expressed to the nearest ten calorie increment [21 CFR 101.9(c)(1)];
• Vitamins and minerals are not expressed to the nearest 5-percent increment greater than the 10-percent level and including the 50-percent level as required [21 CFR 101.9(c)(8)(iii)];
• The Nutrition Facts Panel fails to include “Percent Daily Value” or its abbreviation following each listed daily value percentage [21 CFR
For more information about FDA's food labeling requirements more generally http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
For additional information on trans fat labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
This letter may not list all the violations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations, including the Good Manufacturing Practice regulations (21 CFR Part 110). You are also responsible for ensuring that all of your products are labeled in compliance with the laws and regulations enforced by FDA.
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice, including, but is not limited to, seizure and/or injunction.
A review of our files finds that you made promises to correct the same or similar sanitation and labeling problems noted during our previous inspections of 2007, 2009, and our current 2010 inspection. However, sanitation and labeling violations continue at your facility despite your past promises to take corrective action.
Your Tridas Receta Original (Tridas Original Recipe Cheese), Tridas Pasta y Queso “Guayaba” (Tridas Guava Paste and Cheese), and Tridas Pasta y Queso “Mango” (Tridas Mango Paste and Cheese) product labels contain information in two languages, but do not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
2. The product label for your Tridas Receta Original (Tridas Original Recipe Cheese), Tridas Pasta y Queso “Guayaba” (Tridas Guava Paste and Cheese), and Tridas Pasta y Queso “Mango” (Tridas Mango Paste and Cheese) lists “mucho carino” (much care or love), which is intervening material and not appropriate in the ingredient statement. Under 21 CFR 101.2(e), all information required to appear on the information panel shall appear without intervening material.
3. Your Tridas Receta Original (Tridas Original Recipe Cheese) product is missing the letter “A” in the declaration of Vitamin A.
4. If the sodium benzoate is functioning as a preservative in the finished product, the product must bear a label declaration stating included in accordance with the requirements of section 403(k) of the Act and 21 CFR 101.22(j).
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done to correct these violations. You should include in your response documentation, such as records, labels, or photographs, of the corrective and preventive actions taken by your firm, 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.
Your written reply should be addressed to the Food and Drug Administration, Attention: Carlos I. Medina, Compliance Officer, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions concerning the violations noted please contact Mr. Medina at (787) 474-9539 or by electronic mail at email@example.com.
Maridalia Torres Irizarry
San Juan District Office