United States v. S. Serra Cheese Co., Case No. 14-13077
| Decision Date | 20 October 2015 |
| Docket Number | Case No. 14-13077 |
| Parties | UNITED STATES OF AMERICA, Plaintiff, v. S. SERRA CHEESE COMPANY, a corporation, and FINA SERRA and STEFANO SERRA, individuals, Defendants. |
| Court | U.S. District Court — Eastern District of Michigan |
This is a case under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. Plaintiff United States of America (the "Government") is seeking an injunction under 21 U.S.C. § 332(a), against Defendants S. Serra Cheese Company, Fina Serra, and Stefano Serra (collectively "Serra"), against violating the Federal Food, Drug, and Cosmetic Act (the "Act"). The Government says that Serra continues to violate the Act by introducing and delivering for introduction into interstate commerce adulterated food, a violation of 21 U.S.C. § 331(a). In addition, the Government says that Serra is adulterating food while it is held for sale after shipment of one or more of its components in interstate commerce, a violation of 21 U.S.C. § 331(k).
Now before the Court is the Government's motion seeking summary judgment and entry of a permanent injunction (Doc. 24). For the reasons that follow, the Government's motion for summary judgment is GRANTED. Also, the Government is entitled to a permanent injunction, the text of which is still an open question.
Serra is a Michigan corporation that has operated for over 16 years. Serra prepares, processes, packs, holds, and distributes an assortment of ready-to-eat ("RTE") cheeses, including ricotta, provolone, mozzarella, and primo sale. Its products are manufactured in Serra's facility (the "facility") located in Clinton Township, Michigan. Fina and Stefano Serra are co-owners of Serra. Serra ships its cheeses to retail and wholesale customers located outside Michigan and receives ingredients used to make its cheeses from sources outside Michigan.
Listeria is a genus of bacteria found in soil and water and some animals, including cattle. Listeria can be present in raw milk and can live in food processing plants. Listeria innocua ( ) is one of the species of Listeria. Although L. innocua is not pathogenic, its presence in a food facility is an indicator of insanitary conditions because L. innocua is not a normal bacterial flora of milk. L. innocua is often found in environments that also support the growth of L. monocytogenes ( ), a pathogenic organism that poses an acute, life-threatening hazard to human healthbecause it is the causal agent for the disease listeriosis. Listeriosis can be serious, even fatal, for vulnerable groups such as newborns and those with impaired immune systems, and the four most serious forms of listeriosis can result in meningitis and septicemia. Although the presence of L. innocua in a food facility will not necessarily cause the food prepared there to be contaminated with L. innocua or L. mono, the presence of L. innocua indicates insanitary conditions under which such food is prepared whereby it may be contaminated with filth or rendered injurious to health, because it indicates that other microorganisms, such as L. mono, are likely to survive and flourish in the same processing environment.
Escherichia coli ( ) are a diverse group of bacteria that include pathogenic and non-pathogenic strains. Strains of pathogenic E. coli can cause disease in humans, and their presence in food poses a hazard to human health. Non-pathogenic strains of E. coli (e.g., generic, non-pathogenic E. coli) in food are not commonly associated with human illness, but are used as an indicator of insanitary conditions during processing or contamination with filth. E. coli are not inherently present in the milk of dairy animals, and their presence in milk or other dairy products indicates that the milk or dairy products were exposed either directly or indirectly to feces. Insanitary conditions, including poor employee hygiene practices, improperly sanitized utensils and equipment, and/or contaminated raw materials, may also be a source of E. coli in milk and other dairy products.
Between January 8 and 23, 2013, investigators from the United States Food and Drug Administration (the "FDA") Detroit District Office conducted a comprehensive inspection of the facility (Doc. 1, ¶ 17; Doc. 26, Ex. 3, ¶ 5). The inspection revealed significant violations and resulted in the FDA issuing an eight-item List of Inspectional Observations, Form FDA-483, that included the following: (1) failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 C.F.R. § 110.35(a); (2) failure to construct the facility in such a manner as to allow floors to be adequately cleaned and maintained, as required by 21 C.F.R. § 110.20(b)(4); and (3) failure to store raw materials in a manner that protects against contamination, as required by 21 C.F.R. § 110.80(a)(1) (Doc. 1, ¶ 17). FDA officers discussed the violations with Defendant Fina Serra (Doc. 26, Ex. 3, ¶ 6). Serra did not respond to the January 2013 Form FDA-483 (Doc. 1, ¶ 17).
In June 2013, the FDA issued a Warning Letter to Defendant Fina Serra that discussed the current good manufacturing ("cGMP") violations noted during the January 2013 inspection and advised that samples collected during the inspection revealed L. innocua in the facility and generic, non-pathogenic E.coli in cheeses (Doc. 26, Ex. 3A). Such findings are indicative of insanitary conditions in the facility. The Warning Letter emphasized the serious nature of the deficiencies and stated that it was Serra's responsibility to ensure that its products comply with the Act (Doc. 1, ¶ 18). TheWarning Letter further explained that failure to correct these conditions could result in additional regulatory action, including an injunction (Doc. 26, Ex. 3A). In response, Serra promised to correct the insanitary conditions described in the Warning Letter (Doc. 26, Ex. 3B & 3C).
Between October 22 and November 8, 2013, FDA investigators conducted a comprehensive follow up to the January 2013 inspection and June 2013 Warning Letter (Doc. 24, Ex. 1, ¶ 10). This inspection resulted in the issuance of a second FDA Warning Letter addressing significant cGMP violations at the facility similar to those observed previously. Id. The inspection revealed that Serra failed to implement effective corrections to remedy the insanitary conditions previously observed at the facility. Id. The Warning Letter included the following observations: (1) Serra failed to perform filling and assembling in a manner that protects food from being contaminated, in violation of 21 C.F.R. § 110.80(b)(13); (2) Serra failed to take effective measures to protect finished food from contamination by raw materials, as required by 21 C.F.R. § 110.80(b)(6); (3) Serra failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food contact surfaces, in violation of 21 C.F.R. § 110.35(a); (4) Serra failed to construct the facility in such a manner as to allow floors to be adequately cleaned and kept clean and in good repair, in violation of 21 C.F.R. § 110.20(b)(4); and (5) Serra failed to store raw materials in a manner that protects against contamination. (Id. at ¶¶ 10(A)-(E)).
As examples, FDA investigators observed the following violations:
During the November inspection, FDA inspectors collected 71 samples from the facility and laboratory analyses found L. innocua throughout the facility, including in eleven locations in close proximity to food (Doc. 24, Ex. 1, ¶ 11). In addition, analysis of sample number 794150 found significant levels of generic, non-pathogenic E.coli in finished RTE primo sale cheese (Doc. 24, Ex. 1, ¶ 12).
The FDA issued a seven-item Form FDA-483 to Defendant Fina Serra at the close of the November 2013 inspection (Doc. 24, Ex. 1, ¶ 14). FDA Consumer Safety Officer Margaret Persich discussed the observations noted in the Form FDA-483 with Fina Serra and explained that the FDA might seek further regulatory action, including a permanent injunction. Id. Fina Serra responded to the November 2013 inspection in an undated letter to the FDA received on January 22, 2014, representing that actions had been and were being taken to correct the cGMP violations identified in the November 2013 inspection (Doc. 26, Ex. 3D).
On March 23, 2015, Serra submitted to the FDA documentation stating that it conducted certain chemical cleaning activities at the facility. As part of the submission, Serra provided analytical results of environmental samples it had collected at the facility on March 13, 2015 (Doc No. 25, ¶ 18). The results showed...
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