Empresas Y-nuina, Inc. 11/16/10
Department of Health and Human Services
Public Health Service
Food and Drug Administration
San Juan District
466 Fernandez Juncos Avenue
San Juan Puerto Rico 00901-3223
November 16, 2010
RETURN RECEIPT REQUESTED
Enrique Mangual Flores
Empresas Y-Nuina, Inc.
P.O. Box 1661
Canóvanas, PR 00729
Dear Mr. Mangual Flores:
We inspected your seafood processing facility located at RD 185, Km 0.8, Canóvanas, Puerto Rico on
June 28 and 29, and July 6, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your plantain fritters (‘alcapurias’), mini plantain fritters (‘mini alcapurias’), tacos, and mini tacos with crab meat are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at
In addition, our inspection revealed CGMP violations that affect all food products at your facility. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110
, renders your firm’s products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C.
Your significant violations were as follow:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a)
and (c)(2). A critical control point is defined in 21 CFR 123.3(b)
as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for alcapurrias, mini alcapurrias, tacos, and mini tacos with crabmeat does not list the critical control points of:
thawing of frozen crabmeat after receiving for controlling the food safety hazard of pathogen growth and potential toxin formation, and
cooler storage of product after cooking for controlling the food safety hazard of pathogen growth including
Pathogen growth is reasonably likely to occur in the absence of controlled thawing.
We recommend thawing take place at temperature of 40
F or below and the process be monitored continuously for both time and temperature. In addition, after the cooking process, your firm stores unused cooked crabmeat in a
or for longer periods. Pathogen growth is reasonably likely under these conditions. Continuous monitoring at 40
F is recommended. For continuous monitoring, FDA recommends the use of equipment capable of monitoring and recording refrigerated temperatures on a 24 hour a day/7 day a week basis, with a daily check of the temperature records and a daily check of the equipment.
You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for alcapurrias, mini alcapurrias, tacos, and mini tacos with crabmeat does not list the food safety hazard of “allergens” associated with the allergenic substances that are included in the finished products. FDA recommends that in order to control the food safety hazard of allergens, firms include a critical control point for labeling and visually check one label from each lot of labels, to ensure that the allergenic substances are properly declared on the label.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing requirements in 21 CFR Part 110
, to comply with 21 CFR 123.11(b)
. However, your firm did not monitor the protection of food, food packaging material, and food contact surfaces from adulteration with condensates, as evidenced by accumulation of ice condensation on a pallet containing carton boxes of plantain fritters dough in freezer
Current Good Manufacturing Practices
1. All persons working in direct contact with food, food-contact surfaces, and food packaging materials must
wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work and after each absence from a work station to comply with
21 CFR 110.10(b)(3). However, on June 29, 2010, it was observed that
employees returning from lunch, the bathroom, or a break did not wash their hands with soap prior to handling turnover shells with their bare hands. They briefly rinsed their hands with water and touched the surface of the trash can lid when discarding the paper towel used to dry their hands.
employees filling turnover shells with product did not wash their hands after inserting them in their street clothes pockets.
2. All persons working in direct contact with food, food-contact surfaces, and food packaging materials must wear suitable outer garments during processing of foods
that protect against contamination of food and food contact surfaces, to comply with
21 CFR 110.10(b)(1). However, on June 29, 2010, it was observed that employees left the food processing area wearing their work coat and hair nets. These protective garments were not changed upon returning to work.
3. You must take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c)
. However, our inspection revealed an open ceiling area above a dough manufacturing machine located in the production area, allowing for the potential ingress of pests. In addition, an accumulation of spider webs was observed on a section of the flour dispensing funnel located below the open area.
We acknowledge your response, dated July 27, 2010, in which you state that you have taken certain corrective actions. However, the actions outlined in your response letter have not fully addressed all our concerns.
Please submit documentation which shows completion of corrections (e.g., a revised HACCP plan, revised SSOPs, photographs or receipts that verify modifications, etc.). The adequacy of your corrective actions and their implementation will be assessed during our next inspection.
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 HACCP and verification 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, the seafood HACCP regulation (21 CFR Part 123
) 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.
Please send your reply to the Food and Drug Administration, Attention:
Carlos I. Medina. If you have questions regarding any issues in this letter, please contact Carlos I. Medinaat 787-474-9539
San Juan District