Inspections, Compliance, Enforcement, and Criminal Investigations
Corporacion Avicola Morovis Inc 6/30/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Juan District|
466 Fernandez Juncos
San Juan, Puerto Rico 00901-3223
JUN 30 2014
RETURN RECEIPT REQUESTED
RETURN RECEIPT REQUESTED
Mr. Juan De La Vega
Co-Owner and Administrator
Corporacion Avicola Morovis, Inc.
P.O. Box 397
Morovis, Puerto Rico 00687
Dear Mr. De La Vega:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at Road 634 Km 2.2, Morovis, Puerto Rico, from March 17 through March 25, 2014. During the inspection, we 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, which was issued to you on March 25, 2014. 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 are as follows:
1. You failed to have a written SE Prevention Plan that includes the SE prevention measures required by 21 CFR 118.4. Specifically, your written SE prevention plan, titled “Corporacion Avicola Morovis, Inc. Programa Bio-Seguridad” failed to include the following required SE prevention measures:
A. Your SE prevention plan failed to include practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3). You also failed to maintain practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3). Specifically, your farm is set up such that employees may walk on the outside premises in order to move from one poultry house to another. Our investigators observed several stray animals as well as excrement in these areas. During the inspection we noted that no steps are taken to prevent cross-contamination when employees move between houses. Cross contamination between houses can be prevented by a number of methods including footbaths, applying disinfectant spray to foot-wear, and sanitizing hands with appropriate gels.
B. Your SE prevention plan failed to include measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses and you failed to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, our investigators observed that your firm’s high rise poultry houses have no sides, netting, screening or any barrier to prevent wild birds or other animals from entering the poultry houses. During the inspection, our investigators observed the following:
o Numerous wild birds inside your poultry houses nesting in the ceiling, feeding from your poultry’s feed, and leaving excrement on the walkways;
o Wild birds on the manure pits and in the surrounding areas; and
o Four cattle on the manure pits and in the surrounding areas.
C. Your SE prevention plan does not address prohibiting employees from keeping birds at home, as required by 21 CFR 118.4(b)(5). We note that while discussing the firm’s training program the investigators were informed that employees are verbally told they are prohibited from owning birds while employed; however, this requirement was not included in the written SE prevention plan.
D. You failed to have and implement an 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 did not contain fly monitoring procedures, and you acknowledged to our investigators that you do not monitor for flies in your poultry houses. Your SE prevention plan must address monitoring for flies by spot cards, Scudder grills, or sticky traps or another appropriate monitoring method. When monitoring indicates unacceptable fly activity within a poultry house, 21 CFR 118.4(c)(2) requires you to use appropriate methods to achieve satisfactory fly control.
E. Your SE prevention plan failed to include a requirement that chicks be procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan’s standards for “U.S. S. Enteritidis Clean” status or equivalent standard, as required by 21 CFR 118.4(a)(1). We note that during the inspection you provided a NPIP Form 9-3 for chicks purchased from (b)(4) on May 1, 2013 documenting that chicks were procured from SE-monitored breeder flocks that meet the NPIP standards for “U.S.S. Enteritidis Clean” status or equivalent standard. However, your SE prevention plan must include the requirements of 21 CFR 118.4(a)(1).
F. Your SE prevention plan failed to include an appropriate monitoring method for rodents, as required by 21 CFR 118.4(c)(1). Specifically, your plan does not provide thresholds that would trigger corrective actions or describe what those corrective actions would be. 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.
We received your undated written response to the FDA 483 on April 8, 2014. Your response states that you will add procedures for fly monitoring, controlling wild birds, and preventing cross contamination, to your bio-security program. Your response also states that you will order footbaths for use between your poultry houses and that you will cover your poultry houses with netting to prevent wild birds and other animals from entering the poultry houses. However, you did not include a revised SE prevention plan or provide any supporting documentation of your corrective actions. We will evaluate the adequacy of your corrective actions during our next inspection of your farm.
2. You failed to conduct environmental testing for SE in the pullet environment when the pullets were 14 to 16 weeks of age as required by 21 CFR 118.4(a)(2)(i). Specifically, your chicks were hatched on May 1, 2013 according to receipts from (b)(4) and verified by the (b)(4) you provided. Based on this hatch date, the chicks would have been 14 weeks of age on August 7, 2013; however, the pullet environment was tested for SE on August 2, 2013, according to the invoice from “(b)(4) Laboratory Analysis Report, Date/Time of Sampling.” Therefore the pullet environment was tested for SE at a point prior to the chicks turning 14 weeks of age.
3. Your SE prevention plan did not include the name and address of your farm, as required by 21 CFR 118.10(b)(1). Additionally, your written SE prevention plan was not signed and dated by the SE plan administrator as required by 21 CFR 118.10(b)(3).
This letter is not intended 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 further 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).
In addition to the violations above, we have the following comments:
· We note that your written SE prevention plan refers several times to “vaccinations required by FDA.” Please note that FDA does not require any vaccinations. The egg rule only requires that pullets come from SE-monitored breeder flocks.
· You maintain temperature monitoring records which state that the temperature must be maintained at (b)(4) for the refrigerated trucks used to transport eggs. We observed no refrigeration deficiencies during the inspection; however, we note that refrigeration, which is required by 21 CFR 118.4(e), must be addressed in your written SE prevention plan. Further, to ensure that eggs are held at or (b)(4) ambient temperature (b)(4), your SE prevention plan should include information regarding when your last collection of the day occurs. Our investigator observed that the collection time is between approximately (b)(4).; however, this practice is not documented in your written SE prevention plan.
· The “House Management” section of your written SE Prevention plan calls for testing of (b)(4) eggs if your firm receives notification of a positive SE environmental test. FDA notes that to meet the egg testing requirements of 21 CFR 118.6(c), you must collect and deliver for testing a minimum of (b)(4) representative of a day's production as required by 21 CFR 118.7(b)(1). The (b)(4) sample must be tested according to 21 CFR 118.8. You must collect and test (b)(4) egg samples at (b)(4) intervals for a total of (b)(4) (see 21 CFR 118.7(b)(1)). We note that one of the flow charts included in the plan does reflect the (b)(4) samples that are required. However, the narrative portion of your plan refers to a (b)(4) egg sample, which would not be adequate.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken or plan to take to correct the violations noted above, and to ensure that similar violations do not occur. You should include in your response any documentation necessary to show that corrective action has been achieved, such as an updated written SE prevention plan and monitoring records. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Please send your written response to the attention of Mr. Carlos A. Medina, Compliance Officer, Food and Drug Administration, San Juan District Office.. If you have any questions regarding any issue in this letter, please contact Mr. Carlos A. Medina at (787) 729-8617 or via email at firstname.lastname@example.org.
San Juan District