1

UNITED STATES DISTRICT COURT 

EASTERN DISTRICT OF MICHIGAN 

SOUTHERN DIVISION 

UNITED STATES OF AMERICA, 

 Plaintiff, Case No. 14-13077 

v. HON. AVERN COHN 

S. SERRA CHEESE COMPANY, 

a corporation, 

 and 

FINA SERRA and STEFANO SERRA, 

individuals, 

 

 Defendants. 

_______________________________________/

DECISION AND ORDER GRANTING 

PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT (Doc. 24) 

I. INTRODUCTION 

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). 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 1 of 15 Pg ID 779
2

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. 

II. BACKGROUND 

A. Serra’s History

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. 

B. Listeria and E. Coli1

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 (“L. 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 (“L. mono”), a 

pathogenic organism that poses an acute, life-threatening hazard to human health 

 

1

 This section is taken from the Declaration of Dr. Obianuju N. Nsofor, Food 

Microbiologist for the Division of Dairy, Egg, and Meat Products within the Office of 

Food Safety at the Center for Food Safety and Applied Nutrition (“CFSAN”), United 

States Food and Drug Administration (“FDA”), Department of Health and Human 

Services (Doc. 25).

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 2 of 15 Pg ID 780
3

because 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 (“E. 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. 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 3 of 15 Pg ID 781
4

C. Violations Observed During FDA Inspections 

1. January 2013 Inspection 

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). 

2. June 2013 Warning Letter 

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). The 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 4 of 15 Pg ID 782
5

Warning 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). 

3. November 2013 Inspection 

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)). 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 5 of 15 Pg ID 783
6

As examples, FDA investigators observed the following violations: 

 An employee dropped a piece of plastic wrapping on the processing room 

floor which was unclean and wet with milk, and without cleaning it, picked 

it up and wrapped RTE provolone cheese with it (Doc. 24, Ex. 1, ¶ 10(A)). 

 An employee washed perforated plastic trays on the floor of the facility’s 

processing room immediately before filling the trays with mozzarella 

cheese (Id.). 

 Employees dumped raw milk on the floor in a high-traffic area of the 

processing room (Id. at ¶ 10(B)). 

 An employee used a hose to clean a table in a manner that caused water 

from the table and floor to splatter onto RTE provolone cheese (Id. at ¶ 

10(C)). 

 The concrete floor in the manufacturing area of the facility was pitted and 

porous and some areas of the floor had layers of paint or sealant that 

were cracked, peeling, and chipped. Standing water was observed in all 

areas of the walk-in cooler (Id. at ¶ 10(D)).2

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). 

 

2

 Uneven, pitted, and porous floors are difficult to clean and sanitize adequately and 

standing water on such floors can serve as niches or harborages for L. mono and other 

pathogens, in violation of 21 C.F.R. § 110.20(b)(4) (Doc. 24, Ex. 2, ¶10(D)).

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 6 of 15 Pg ID 784
7

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). 

4. March 2015 Sample Testing Results 

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 that, as of March 13, 2015, 

Listeria spp. was present at multiple locations in the facility’s environment, including on 

the production floor. Id. The locations where Listeria spp. was detected on March 13, 

2015 were: Cooler Room #1 Drain; Cooler Room #3 Drain by the Door; Production 

Small Drain; and Production Center Floor (Doc. 26, Ex. 2G). 

On March 27, 2015, Serra submitted analytical results to the FDA stating that on 

March 25, 2015, it had collected and tested environmental samples from the specific 

locations from which it had collected environmental samples on March 13, 2015 and 

that had tested positive for Listeria spp. (Doc. No. 25, ¶ 19). Serra’s analytical results 

showed that the environmental samples it had collected on March 25, 2015 were 

negative for Listeria spp. Id. 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 7 of 15 Pg ID 785
8

III. DISCUSSION 

A. Summary Judgment 

The standard for summary judgment is well known and is not repeated in detail. 

“The court shall grant summary judgment if the movant shows that there is no genuine 

dispute as to any material fact and the movant is entitled to judgment as a matter of 

law.” Fed. R. Civ. P. 56(a). Ultimately a district court must determine whether the 

record as a whole presents a genuine issue of material fact drawing “all justifiable 

inferences in the light most favorable to the non-moving party.” Hager v. Pike Cnty. Bd. 

of Ed., 286 F.3d 366, 370 (6th Cir. 2002).

B. Overview 

The Government says that Serra has violated the Act, 21 U.S.C. § 331(a) and 

(k). Section 331(a) prohibits “the introduction or delivery for introduction into interstate 

commerce of any food...that is adulterated...” 21 U.S.C. § 331(a). Section 331(k) 

prohibits “the doing of any other act with respect to, a food...if such act is done while 

such article is held for sale (whether or not the first sale) after shipment in interstate 

commerce and results in such article being adulterated...” 21 U.S.C. § 331(k). To 

establish these violations, the Government has the burden to establish that (1) Serra’s 

products are “food” within the meaning of the Act; (2) that the food was “adulterated” as 

the FDCA defines that term; and (3) that the food moved in interstate commerce. United 

States v. Am. Mercantile Corp., 889 F. Supp. 2d 1058, 1071 (W.D. Tenn. 2012). 

According to the Government, there is no genuine issue of material fact. The 

Government points out that neither party disputes whether Serra’s products are “food” 

or if the product travels in interstate commerce (Doc 36, ¶¶ 6-7). Serra’s Response to 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 8 of 15 Pg ID 786
9

the Motion for Summary Judgment focuses on whether or not its product is adulterated 

and whether the relief being sought is an appropriate remedy (Doc. 30). Because both 

Serra and the Government focus on the second element and admit the establishment of 

the first and third elements in their Joint Statement of Facts, the Court finds that there 

are no genuine issues of material fact regarding the first and third elements and will 

focus solely on the second element, as well. 

C. “Adulterated” Food as Defined by the Act 

A food is adulterated “if it has been prepared, packed, or held under insanitary 

conditions whereby it may have become contaminated with filth, or whereby it may have 

been rendered injurious to health.” 21 U.S.C. § 342(a)(4). This provision of the Act 

pertains solely to the conditions under which food is prepared, packaged, or held; it is 

not necessary to prove that the food itself actually contains filth or is injurious to health. 

To establish adulteration under 21 U.S.C. § 342(a)(4), the government need only show 

a reasonable probability that, because of the insanitary conditions under which food is 

prepared, packed, or held, food may have been rendered filthy or injurious to health. 

United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 90-91 (1964); Berger v. 

United States, 200 F.2d 818, 821 (8th Cir. 1952); United States v. Gel Spice Co., Inc., 

601 F. Supp. 1205, 1211 (E.D.N.Y. 1984). Proof of actual contamination is not required. 

United States v. Gel Spice Co., 773 F.2d 427, 429 (2nd Cir. 1985); United States v. 

King’s Trading, Inc., 724 F.2d 631, 632 (8th Cir. 1983). “Even so, proof of actual 

contamination is prima facie evidence that the food has been held under insanitary 

conditions.” Am. Mercantile Corp., 889 F. Supp. at 1076. Similarly, “the existence of 

insanitary conditions adjacent to food will create a reasonable possibility that the food 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 9 of 15 Pg ID 787
10

may become contaminated.” Id. To prevent insanitary conditions that render their 

products adulterated, Serra must comply with the Act’s cGMP regulations, 21 C.F.R. 

Part 110. The question of insanitary conditions is determined from the totality of the 

circumstances. Am. Mercantile Corp., 889 F. Supp. 2d at 1076. 

D. Analysis 

The facts of record establish that Serra’s product is adulterated under 21 U.S.C. 

§ 342(a)(4). The FDA’s inspections of the facility, the numerous product sample results 

collected by the FDA, and Serra’s own positive sample analyses all demonstrate that 

Serra repeatedly introduced adulterated food into interstate commerce and caused food 

to become adulterated while held for sale after shipment in interstate commerce. Serra 

proffers several arguments for why the Government’s summary judgment should be 

denied. Serra’s arguments are without merit as the Court will discuss below. 

1. Findings from FDA Inspections Establish Violation of the Act’s cGMPs

As noted supra, the Government has proffered multiple examples of Serra’s 

violations of the Act’s cGMPs, including but not limited to: Serra’s failure to perform 

filling and assembling in a manner that protects food from becoming contaminated, in 

violation of 21 C.F.R. § 110.80(b)(13); Serra’s failure to take effective measures to 

protect finished food from contamination by raw materials, such as raw, unpasteurized 

milk, in violation of 21 C.F.R. § 110.80(b)(6); Serra’s repeated failure 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); etc. 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 10 of 15 Pg ID 788
11

In response, Serra says that the inspections alluded to in the Government’s 

Complaint were conducted in 2013 and the necessary refurbishments and 

improvements to address the violations have been accomplished since then (Def. Resp. 

to Pl. Motion for Summ. Judgment, Doc. 30 at 12). This argument lacks merit. Aside 

from the assertions in its brief, Serra has not established proof of the assertions. 

Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87 (1986)(nonmoving party “must do more than simply show that there is some metaphysical doubt as 

to material facts...[and] come forward with specific facts showing that there is a genuine 

issue for trial”). Therefore, this argument fails. 

Further, Serra argues that it is “highly questionable” whether the Government’s 

observations actually constitute a finding of “filth” as required by the Act. This argument 

lacks merit. Also, actual contamination is not required – only reasonable possibility. For 

example, Serra says that the fact that a FDA representative observed an employee 

placing plastic wrap that fell on the floor onto cheese without cleaning the wrap does not 

mean that the cheese was actually put out into the marketplace (Doc. 30 at 14). 

However, there is a reasonable possibility that the cheese was put out into the 

marketplace; that is enough. 

2. Sickness is Not a Required Element 

Serra also says that it has not violated the Act because no one has reported 

sickness from eating Serra products (Doc. 30 at 8).This argument is also without merit. 

Actual contamination is not an element of adulteration under 21 U.S.C. § 342(a)(4). 

Food is adulterated simply if it has been held under insanitary conditions whereby it may 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 11 of 15 Pg ID 789
12

have become contaminated with filth or whereby it may have been rendered injurious to 

health. Id. Actual contamination is not required. King’s Trading, Inc., 724 F.2d at 632. 

3. Reasonable Possibility of Contamination is Sufficient – 

Actual Contamination is Not Required 

Serra says that because the FDA did not find pathogenic L. mono. and E. coli 

contamination at the facility and because Serra only uses pasteurized milk for its 

cheese products, the food produced at the facility is not adulterated. (Doc. 30 at 7-8). 

This argument is without merit. The Government is not required to show actual 

contamination or injury under 21 U.S.C. § 342(a)(4). Food is “adulterated” simply if it 

has been held under insanitary conditions whereby there is a reasonable possibility for it 

to become contaminated with filth. Serra mistakenly bases its argument against 

adulteration on the fact that the samples taken showed non-pathogenic L. innocua and 

E. coli. (Doc. 30 at 7-8). However, the Government simply needs to show a reasonable 

possibility of contamination. Based on the observations listed supra of the insanitary 

conditions in the facility in conjunction with the test results finding L. innocua throughout 

the facility and generic E. coli in Serra’s finished cheeses in samples taken from both 

the January 2013 and the November 2013 inspections, the Government has met its 

burden. 

4. Source of Contaminants –Whether the Cheese or Added Ingredients – 

is Not the Issue 

Serra argues that it is uncertain whether the L. innocua and E. coli were found on 

account of the cheese itself or contaminated ingredients added to the cheese (Doc. 30 

at 14). This argument lacks merit. First, as noted above, the key inquiry to determine 

adulteration is not actual contamination but rather reasonable possibility of 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 12 of 15 Pg ID 790
13

contamination. The Government has established the requisite reasonable possibility. 

Further, Serra cannot argue that the finished product is not contaminated simply 

because the cheese it produced is clean and only the added ingredients are 

contaminated. Contaminants in a finished product produce a contaminated product – 

whether the contamination is from the cheese or the added ingredients. 

IV. Injunctive Relief 

A. 

In determining whether to grant the Government’s requested relief under 21 

U.S.C. § 332(a), the Court does not need to consider whether there is an adequate 

legal remedy or irreparable injury. U.S. v. City of Painesville, Ohio, 644 F.2d 1186, 

1193-94 (6th Cir. 1981); U.S. v. Edward Rose & Sons, 246 F. Supp. 2d 744, 753 (E.D. 

Mich. 2003). Because this is a Congressional Act to protect the public health, the 

Government only needs to establish that Serra violated the statute and there is some 

cognizable danger of recurrent violation. Edward Rose & Sons, 246 F. Supp. at 753. 

The Court considers several factors to determine the likelihood of future violations 

including, but not limited to, (1) the isolated or repeated nature of the violations, (2) the 

defendant’s recognition of the wrongful nature of his conduct, and/or (3) the likelihood 

that the defendant’s occupation will present opportunities for future violations. Id. at 753-

54. 

Serra defends against an injunction because it says the Government relies on 

outdated test results and ignores recent improvements to the facility. The argument has 

no merit. The Government has established the violations of the Act as described above. 

The Government is entitled to injunctive relief because Serra repeatedly violated the Act 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 13 of 15 Pg ID 791
14

despite the FDA’s repeated warnings and Serra’s assurances of improvements. Further, 

many of the improvements listed in Serra’s Response to the Government’s Motion for 

Summary Judgment were not instituted until February 2015 – six months after the filing 

of the Government’s complaint (Doc. 30 at 12). Similarly, samples taken from the facility 

as recently as March 13, 2015 show the presence of Listeria spp. in multiple locations 

within the facility, including on the production floor (Obianuju Dec., Doc. 25, ¶ 18). This 

indicates that the changes Serra has implemented have not been sufficient to cure the 

insanitary conditions. The fact that samples taken on March 25, 2015 failed to detect 

Listeria does not establish a state of general cleanliness in the facility overall. 

Even assuming that Serra is now compliant with the Act, the cessation of illegal 

conduct after litigation has commenced is not a reason to deny the Government the 

injunction it seeks. Once a violation of the Act is established, the Court has an obligation 

“to protect the public from a continuation of the harmful and unlawful activities. A trial 

court’s wide discretion in fashioning remedies is not to be exercised to deny relief 

altogether by lightly inferring an abandonment of the unlawful activities from a cessation 

which seems timed to anticipate suit.” U.S. v. Parke, Davis & Co., 362 U.S. 29, 48 

(1960). 

B. 

The particular language of the injunction is yet to be decided. The Court is not 

disposed to immediately close the facility; the fact that it has continued to operate during 

the pendency of the case is of significance. Rather, the Government shall submit the 

form of injunction it believes appropriate within five business days. Serra shall respond 

within five business days. The Court will hold a conference with the parties on 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 14 of 15 Pg ID 792
15

November 5, 2015. If the language of the injunction is not resolved at the conference, 

the Court will hold a formal hearing on November 6, 2015. 

V. CONCLUSION 

For the reasons stated above, the Government’s motion for summary judgment is 

GRANTED. The Court shall proceed as above described. 

SO ORDERED. 

 s/Avern Cohn 

 AVERN COHN 

 UNITED STATES DISTRICT JUDGE 

Dated: October 20, 2015 

Detroit, Michigan 

2:14-cv-13077-AC-MJH Doc # 38 Filed 10/20/15 Pg 15 of 15 Pg ID 793