Inspections, Compliance, Enforcement, and Criminal Investigations

Lystn, LLC dba Answers Pet Food 3/17/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
16-PHI-05
 
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
March 17, 2016
 
 
Mr. Keith A. Hill, President
Lystn, LLC
DBA Answers Pet Food
356 Maidencreek Road
Fleetwood, PA 19522
 
Dear Mr. Hill:
 
On October 5, 2015, FDA tested samples of your Detailed Answers Chicken Formula dog food. These products were contract manufactured by (b)(4). FDA analysis revealed the products to be contaminated with Salmonella. Specifically, sample #862407 for the Detailed Answers Chicken, 8 ounce raw chicken patties, revealed Salmonella Enteritidis, and sample #913964 for the Detailed Answers Chicken Formula, 2 pounder, revealed Salmonella Kentucky.
 
FDA’s concerns with Salmonella-contaminated pet foods are two-fold: safety of the animals consuming the product and safety of the humans in the same household. It is more common to have human illnesses linked to contaminated pet food or treats than it is to have an animal illness. The association between human outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established by the Centers for Disease Control and Prevention (CDC). 
 
Because exposure to Salmonella spp. can cause serious adverse health consequences or death to humans or animals, in July 2013, FDA issued a Compliance Policy Guide (CPG) addressing the presence of Salmonella in Food for Animals, CPG 690.800. http://www.fda.gov/downloads/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm361105.pdf. Therefore, the above products are adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. §342(a)(1).
 
Between September 3 through 30, 2015, representatives of the FDA conducted an inspection of your facility located at 356 Maidencreek Road, Fleetwood, PA; your contract manufacturer, located at (b)(4), and your (b)(4) facilities, located at (b)(4) and (b)(4) respectively. These inspections confirmed that you manufactured, introduced and delivered for introduction into interstate commerce, a food that is adulterated, and as such is prohibited under section 301(a) of the Federa1 Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 331(a).
 
In addition, your website makes mention to your reliance on cultured whey and montmorillonite, which are food additives, to control “harmful bacteria”; this is beyond their established intended use. As FDA moves forward with implementing preventive controls for food for animals within the Food Safety Modernization Act, firms will be required to validate any method to control a known or foreseeable hazard requiring a preventive control.
 
Your Chicken Formula dog food products are food under section 201(f) of the Act, 21 U.S.C. § 321(f), because they are articles used for food for animals. The (b)(4) cultured whey, montmorillonite, and vitamin E used in these products are food additives under section 201(s) of the Act, 21 U.S.C. § 321(s), because they are components of the food, and the intended use is not in conformity with a regulation prescribing the conditions under which the additive(s) may be safely used. This causes your firm’s Chicken Formula dog food products to be adulterated within the meaning of Section 409(a)(2) of the Act [21 U.S.C. § 348(a)(2)].
 
FDA’s regulations in Title 21 Code of Federal Regulations (21 CFR Part 570) describe the eligibility criteria for classification of a substance added to animal food as generally recognized as safe (GRAS). Under 21 CFR 570.30, general recognition of safety must be based on the views of qualified experts. The basis of such view may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food.  Further, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.
 
Further, your firm failed to file a Reportable Food Report (RFR) within 24 hours as required by the Food Drug and Cosmetic Act (FD&C Act), Section 417.
 
FDA acknowledges the written responses we have received. Although your responses are very extensive, they do not specify what corrective action, if any, you intend or propose to take regarding the above products. 
 
The above is not intended to be an all-inclusive list of violations. You are responsible for assuring that your overall operation and any products you manufacture and distribute are in compliance with the law. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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 fifteen (15) working days of receiving this letter, 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.
 
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.
 
Your written response should be sent to Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215)717-3076 or e-mail at robin.rivers@FDA.HHS.GOV.
 
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District Office

Page Last Updated: 05/19/2016
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