C.C. & Son Farms, Incorporated 9/12/12

WARNING LETTER

VIA UPS
Signature Required

September 12, 2012

Mr. Ching Chi Su, President
C.C. & Son Farms, Incorporated
20096 E. River Rd.
Ripon, California 95366

Dear Mr. Su:

The U.S. Food and Drug Administration (FDA) inspected your shell egg production facility located at 20096 E. River Rd. Ripon, California on April 23^rd, 24^th, and 26^th, 2012.  During the inspection, FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis 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 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 presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspection on April 26, 2012.  You may find the Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov. 

Your significant violations are as follows:

1. You failed to conduct testing to detect SE in environmental samples using 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, as required by 21 CFR 118.8(a).  Specifically, your sampling plan does not account for sampling of all manure piles with a separate drag swab, but rather states that one swab will be used to sample two manure rows.  We do not consider using a drag swab to sample more than one manure bank to be an equivalent method in accuracy, precision and sensitivity in detecting SE.  A different drag swab should be used for each manure bank to avoid saturation of the swab and potential masking of SE by other bacteria. 

During the close-out meeting with our investigators, you did not state that you would change your environmental sampling method.  We will evaluate the adequacy of your corrective action during our next inspection of your facility. 

2. You failed to have a written SE Prevention Plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4.  Specifically, your written SE Prevention Plan entitled “C.C. & Son Farms Inc. (b)(4) does not include procedures for achieving the refrigeration requirements for holding eggs at or below 45 degrees F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e).

During the close-out meeting, you told our investigators that you would correct your SE Prevention Plan.  However, you did not submit a written response to the FDA-483 or provide any supporting documentation of your corrective action.  We will evaluate the adequacy of your corrective action during our next inspection of your facility. 

3. You failed to maintain records documenting compliance with SE prevention measures, including biosecurity measures, as required by 21 CFR 118.10(a)(3)(i).  Specifically, item 12 of your SE Prevention Plan states that you will maintain an appropriate biosecurity plan, will train employees on proper procedures to execute the program, and that you will document employee training and comprehension annually. However, during our inspection, you stated that you did not have records of biosecurity training for (b)(4) employees that work in Poultry House 1.

During the close-out meeting, you told our investigators that you would document your employees’ biosecurity training.  However, you did not submit a written response to the FDA-483 or provide any supporting documentation of your corrective action.  We will evaluate the adequacy of your corrective action during our next inspection of your facility. 

4. You failed to remove debris outside a poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3).  Specifically, our investigators observed piles of debris, including tires, wood, metal parts, and feed tanks not in use, stored near and in contact with the exterior of the east wall of Poultry House 1.

During the close-out meeting, you told our investigators that you would remove this debris.  However, you did not submit a written response to the FDA-483 or provide any supporting documentation of your corrective action.  We will evaluate the adequacy of your corrective action during our next inspection of your facility. 

5. You failed to include the location of your farm on all of your required records, as required by 21 CFR 118.10(b)(1).  Specifically, your written SE Prevention Plan entitled “C.C. & Son Farms Inc. (b)(4),”  and your record entitled “C.C. & Son Farms Inc. (b)(4)” do not include the location of your farm at 20096 E. River Rd, Ripon, CA, 95366.

During the close-out meeting, you told our investigators that you would make this change to your SE Prevention Plan and record.  However, you did not submit a written response to the FDA-483 or provide any supporting documentation of your corrective action.  We will evaluate the adequacy of your corrective action during our next inspection of your facility. 

6. You failed to include the time of the activities reflected in your records, as required by 21 CFR 118.10(b)(2).  Specifically, your records documenting compliance with rodent control measures entitled “C.C. & Son Farms Inc. (b)(4)” do not include the time of the activity for the dates 2/18/12, 2/29/12, 3/10/12, 3/31/12, 4/6/12, and 4/20/12.  Additionally, your records documenting compliance with fly control measures entitled “C.C. & Son Farms Inc. 20096 E. River Rd. Ripon CA” do not include the time of the activity for the dates 1/6/12, 2/6/12, 3/6/12, and 4/6/12.

During the close-out meeting, you told our investigators that you would make this change to your records.  However, you did not submit a written response to the FDA-483 or provide any supporting documentation of your corrective action.  We will evaluate the adequacy of your corrective action during our next inspection of your facility. 

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 Act, the PHS Act, and the shell egg regulation.  You also have a 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 above violations, we also have the following comments:

• The sampling plan attached to your SE Prevention Plan, dated 12/01/2010, and entitled “Environmental Monitoring Procedures for Poultry Facilities” from your veterinarian (whom you authorized to collect environmental swab samples from your laying house at 20096 E. River Road), indicates that 3-4 swabs will be pooled together in one (b)(4) bag, rather than placing each swab in a separate whirlpak-type bag as indicated by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008.  Please note that you must conduct testing to detect SE in environmental samples using 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, as required by 21 CFR 118.8(a).  If you intend to continue using a sampling protocol other than that which is described in the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” we encourage you to submit additional documentation to FDA, so that we can determine if your testing methodology, in light of your sampling protocol, is equivalent in accuracy, precision, and sensitivity in detecting SE.

• Your SE Prevention Plan indicates that you test the pullet environment between (b)(4) weeks of age instead of 14-16 weeks of age as required by 21 CFR 118.4(a)(2)(i).  Although we did not find any testing records that document testing outside of the 14-16 week pullet age time frame, we recommend revising your firm’s SE Prevention Plan to include the 14-16 week time frame.  In addition, we note that you must keep a record of modifications to your SE Prevention Plan, as required by 21 CFR 118.10(a)(4).

• Your SE Prevention Plan defines a “flock” as a group of birds the same approximate age, which is in contrast to how a “flock” is defined in 21 CFR 118.3 as all laying hens within one poultry house. 

• Your SE Prevention Plan (Appendix V) indicates that if egg testing is initiated, a date will be set for the first submission of 1,000 eggs “ASAP.”  Please note that under 21 CFR 118.5(a)(2)(ii), results of egg testing must be obtained within 10 calendar days of receiving notification of a positive environmental test.  Similarly, under 21 CFR 118.5(b)(2)(ii), results of egg testing must be available within 10 calendar days of receiving notification that the environmental test conducted at 4 to 6 weeks after the end of a molting process was positive.

• The pest control program in your SE Prevention Plan indicates that if your fly numbers increase two fold “from the average numbers recorded over the past several recording periods,” then you will intensify your fly control methods.  We recommend that the threshold for taking corrective action be based on a determination of what level of fly activity is unacceptable, in accordance with 21 CFR 118.4(c)(2).

• Your SE Prevention Plan includes a section for handling chicks found positive for SE.  This section does not account for any egg testing if these SE-positive chicks are retained.  In accordance with 21 CFR 118.6(a)(2), egg testing must begin at the onset of production when an SE-positive environmental test is found at any time during the life of a flock.

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur.  Your response should include any documentation necessary to show that corrective action has been achieved, such as an updated SE Prevention Plan, environmental sampling plan, biosecurity training records, and evidence of debris removal.  If you cannot complete corrective actions to your facility within 15 working days, state the reason for the delay and the time within which corrections will be completed.

Your written response to this letter should be directed to Lawton W. Lum, Director of Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502.  If you have any questions regarding any issue in this letter, please contact Aleta T. Flores, Compliance Officer at 510-337-6821.

Sincerely,

/S/

Barbara J. Cassens
Director
San Francisco District 
U.S. Food and Drug Administration