WARNING LETTER

Avicola Santos, Inc. MARCS-CMS 508164 — January 17, 2017

Delivery Method:: United Parcel Service

Recipient:: Recipient Name

Mr. Melvin A. Santos Rodriguez; Avicola Santos, Inc.; 24 Calle Kennedy
Cidra, 00739
United States

Issuing Office:: San Juan District Office; United States

San Juan District

Compliance Branch

466 Avenida Fernández Juncos

San Juan, Puerto Rico 00901-3223

Tel: (787) 729-8500

January 17, 2017

WARNING LETTER

17-SJN-WL-02 / CMS No. 508164

UNITED PARCEL SERVICE
NEXT DAY DELIVERY – SIGNATURE REQUIRED

Mr. Melvin A. Santos Rodriguez

Avicola Santos, Inc.

24 Calle Kennedy

Cidra, Puerto Rico 00739-3405

Dear Mr. Santos:

The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at Carr. 727 KM 0.6, Bo. La Plata, Aibonito Puerto Rico, on August 8 through August 24, 2016. During the inspection, FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 whereby they may have been rendered injurious to health. Our investigators’ observations were noted on Form FDA 483, Inspectional Observations, issued to and discussed with you on August 24, 2016. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at http://www.fda.gov/.

Your significant violations were as follows:

1. You failed to have and implement a written SE prevention plan that includes an appropriate monitoring method for rodents, as required by 21 CFR 118.4(c)(1). Specifically, your written SE prevention plan dated May 11, 2016, states that you will monitor bait stations. On August 8, 2016, our investigators observed that you only had one (1) bait trap station located next to the layer house entrance and it lacked a bait block. Further, your plan does not provide a threshold level of unacceptable rodent activity within a poultry house, and, when monitoring indicates unacceptable rodent activity, the methods you will use to achieve satisfactory rodent control as required by 21 CFR 118.4(c)(1). Without a threshold, such as rodent indexing, it is impossible to determine what an unacceptable level of rodent activity is. We note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends a procedure for obtaining a rodent index of rodent activity. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm

Your response received on September 16, 2016, stated that you have added more bait stations inside and outside of the layer house, but did not provide established locations to be monitored. We will evaluate the adequacy of your response and corrective actions during the next inspection.

2. You failed to have and implement a written SE prevention plan that includes an appropriate monitoring method for flies, as required by 21 CFR 118.4(c)(2). Specifically, your SE prevention plan lists different fly counting methods your firm could use to monitor; however, it did not included a map of locations that will be monitored, what method will be used for control, or to determine unacceptable activity. In addition, on August 8, 2016 investigators observed that you did not adequately monitor for fly activity within the poultry house. They observed too numerous to count (TNTC) flies inside the house and its outside premises. We note that, without a threshold such as the spot card index, it is impossible to determine an unacceptable level of fly activity. FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends several procedures for obtaining an appropriate characterization of levels of fly activity. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm.

Your response received on September 16, 2016 stated that you have modified your fly register (Registro de Control de Moscas) and that a designated employee is responsible for the monitoring of the flies; however, your response did not mention any specific procedures or methods you plan to use in order to satisfactorily control flies in your houses. We will evaluate the adequacy of your response and corrective actions during the next inspection.

3. You failed to have adequate biosecurity measures, and/or to implement the “Biosecurity Program” section of your SE prevention plan, to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b):

a) Specifically, your firm failed to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses as required by 21 CFR 118.4(b)(4). On August 8, 2016, our investigators observed three (3) birds inside the layer house and at least three (3) pigeons nest outside the netting wall of the house. Additionally, investigators observed at least ten (10) pigeons and two (2) cows in close proximity to the layer house and the feed silos and noted that the layer house did not have a physical barrier to prevent wild birds, or other animals from entering the layer house.

Your response received on September 16, 2016 indicates you repaired the fence preventing cows from entering the premises, cover/sealed doorframes with a piece of wood around the door frame, and removed the pigeons nest from the netting wall house. Also, you state that you established (b)(4) to prevent birds, animals or any vector, nest or others to get in or close to the house. However, you did not establish a preventive and permanent solution for birds entering your poultry house, like reducing the wire size preventing birds to fly inside the layer house. Further, you did not submit a revised SE preventive plan to include any of these proposed measures, and therefore we are unable to evaluate the adequacy of your response and corrective actions. We will evaluate the adequacy of your response and corrective actions during the next inspection.

b) Your firm failed to follow the measures in your written SE prevention plan for limiting visitors on the farm as required by 21 CFR 118.4(b)(1). Specifically, your SE prevention plan dated May 11, 2016, states that you will maintain a visitor’s log for visitors on your farm. However, between July 26, 2016 and August 5, 2016, our investigator observed seven (7) occasions when you did not register visitors, such as customers and off site personnel from an egg packing facility, as evidenced by invoices demonstrating they had made visits to your farm.

Your response received on September 16, 2016 indicates you immediately assigned this responsibility to an employee; however, you did not include any specifics as to the implementation of these measures and that the visitor’s log is being accurately maintained. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.

4. You failed to hold or transport your eggs at or below 45ºF ambient temperature beginning 36 hours after time of lay as required by 21 CFR 118.4(e). Specifically, during the inspection our investigators measured the temperature of your walk-in cooler, where eggs are stored for (b)(4); however, (b)(4) at the time of FDA’s measurement. Your response received on September 16, 2016 states that (b)(4). We will evaluate the adequacy of your response and corrective actions during the next inspection.

5. Your firm’s written SE prevention plan failed to include a sampling plan for conducting environmental tests appropriate to the poultry house layout as required by 21 CFR 118.7(a) or the testing methodology to be used for detecting SE in environmental or egg samples as required by 21 CFR 118.8(a). Specifically, your SE prevention plan dated May 11, 2016, states “(b)(4)” However, the plan does not include a description of a sampling scheme that is appropriate to each of your poultry house layouts, as required by 21 CFR 118.7(a) and a description of the testing methodology that will be used to detect SE in environmental and egg samples taken at your farm as required by 21 CFR 118.8(a).

We note that FDA’s December 2011 “Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation" recommends procedures for collecting representative environmental samples. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm. We also note that testing to detect SE in environmental samples must be conducted by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. The April 2008 Environmental Sampling and Detection of Salmonella Web site is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm, current as of June 26, 2009.

Your response received on September 16, 2016 contained insufficient information to determine whether the sampling scheme modifications in your firm’s revised SE prevention plan are adequate. We will evaluate the adequacy of your response and corrective actions during the next inspection.

The above violations are not meant to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the FD&C Act, the PHS Act, and the shell egg regulation. You also have the responsibility to use procedures to prevent future violations of these statutes and regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).

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 or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.

Your written response should be directed to the Food and Drug Administration, attention: Ms. Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Jose E. Perez-Soto, Compliance Officer, at (787) 729-8729 or via email at Jose.Perez@fda.hhs.gov.

Sincerely,

/S/

Maridalia Torres

District Director

San Juan District