WARNING LETTER

Samuel Zimmerman MARCS-CMS 553340 — September 05, 2018

Recipient:: Recipient Name

Samuel Zimmerman; Samuel Zimmerman; 1853 Himrod Road
Penn Yan, NY 14527-8744
United States

Issuing Office:: New York District Office; United States

WARNING LETTER

CMS # 553340

September 5, 2018

VIA UNITED PARCEL SERVICE

DELIVERY SIGNATURE REQUESTED

Samuel Zimmerman

1853 Himrod Road

Penn Yan, New York 14527-8744

Dear Mr. Zimmerman:

The U.S. Food and Drug Administration (FDA) inspected your shell egg farm, located at 1853 Himrod Road, Penn Yan, New York 14527-8744 on March 22 & 23, 2018. During the inspection, the investigators observed that you have 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 the FDA 483, Inspectional Observations, which was issued to you on March 23, 2018. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links in FDA’s home page at www.fda.gov.

Your significant violations are as follows:

1. Your farm failed to have and implement a written Salmonella Enteritidis prevention plan (“SE Plan”), as required by 21 CFR 118.4. Specifically, your written SE Plan failed to include the following required SE prevention measures:

● Procurement of pullets that are SE monitored or raised under SE monitored conditions

● Biosecurity program;

● Rodents, Flies, & Other Pest Control;

● Procedures for Cleaning & Disinfecting the poultry house; and

● Documenting compliance with the refrigeration requirements.

Specifically, on March 23, 2018, you provided a written SE Plan that was provided to you by your former egg distributor. However, this plan is not signed by a designated SE plan administrator. It only has general information which is not specific to the operations or procedures of your farm, and does not adequately address all the required SE preventive measures in 21 CFR 118.4.

2. Your farm failed to use appropriate rodent monitoring methods as required by 21 CFR 118.4(c)(1). Specifically, your rodent monitoring procedures include only visual observation to monitor for rodents. Your rodent monitoring procedures do not establish thresholds to determine acceptable or unacceptable rodent activity within a poultry house. Further, they do not detail what appropriate corrective actions are to be taken when rodent activity is deemed to be unacceptable to achieve satisfactory rodent control.

3. Your farm failed to use appropriate monitoring methods to monitor for flies, as required by 21 CFR 118.4(c)(2). Specifically, your monitoring procedures include only visual observation to monitor the presence of flies. Your fly monitoring procedures do not establish thresholds to determine acceptable or unacceptable fly activity within a poultry house. Further, they do not detail what corrective actions are to be taken when fly activity is deemed to be unacceptable to achieve satisfactory fly control.

4. Your farm failed to conduct environmental testing for SE in the poultry house when laying hens are 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, your Flock #2 was born on June 23, 2016. At 40-45 week of age (March 31, 2017 through May 4, 2017), environmental testing should have been conducted, as required by 21 CFR 118.5(a); however, you failed to collect an environmental sample during this timeframe. You indicated a sample for Flock #2 was collected “a couple days before July 27, 2017” when that flock was approximately 56-57 weeks of age at the time of sampling. Exhibit 4 collected during the inspection showed these environmental sampling test results were received by the laboratory on July 27, 2017.

5. Your farm failed to maintain records in accordance with 21 CFR 118.10, which includes recordkeeping requirements for a Salmonella Enteritidis (SE) prevention plan. Specifically, there are no records that detail compliance with SE preventive measures such as biosecurity (21 CFR 118.10(a)(3)(i)), rodent and pest control (21 CFR 118.10(a)(3)(ii)), cleaning and disinfection (21 CFR 118.10(a)(3)(iii)), and refrigeration (21 CFR 118.10(a)(3)(iv)).

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).

Further, 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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.

Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.

Sincerely,

/S/

Ronald M. Pace

Program Division Director

Office of Human and Animal Food Operations East – Division 1