US v. Union Cheese Co., 5:95CV801.

• Decision Date: 12 July 1995
• Docket Number: No. 5:95CV801.,5:95CV801.
• Parties: UNITED STATES of America, Plaintiff, v. UNION CHEESE COMPANY, et al., Defendants.
• Court: U.S. District Court — Northern District of Ohio

902 F. Supp. 778

UNITED STATES of America, Plaintiff, v. UNION CHEESE COMPANY, et al., Defendants.

No. 5:95CV801.

United States District Court, N.D. Ohio, Eastern Division.

June 16, 1995.

Order Supplementing Injunction July 12, 1995.

Michael Anne Johnson, Assistant U.S. Attorney, Cleveland, Ohio, Drake Cutini, Dept. of Justice, Office of Consumer Litigation, Washington, DC, and Nancy K. Stade, U.S. Food and Drug Admin., Rockville, MD, for Plaintiff.

Ronald L. Russell, Alliance, Ohio, for Defendants.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

HEMANN, United States Magistrate Judge.

This matter came before the court on June 5, 1995 for trial on the Complaint for Injunction filed by the United States of America pursuant to 21 U.S.C. § 301 et seq. The government's motion for preliminary injunction was consolidated with the trial on the merits pursuant to Federal Rule of Civil Procedure 65(a)(2). Having considered the testimony of the witnesses, the trial exhibits, the memoranda submitted on behalf of the parties, the arguments of counsel and the applicable law, the court makes the following findings of fact and conclusions of law.

FINDINGS OF FACT

Defendant Union Cheese Company ("Union Cheese") is a corporation organized under the laws of the State of Ohio. Union Cheese is engaged in the production and distribution of swiss cheese and the distribution (including cutting and packaging) of other cheeses at its facility in Sugarcreek, Ohio. Union Cheese regularly ships cheese products outside of the State of Ohio. It receives milk shipments from outside of the State of Ohio. Union Cheese produces approximately 20,000 pounds of swiss cheese per day and regularly has 1,000,000 pounds of cheese on hand at its premises. Defendant Dominic Gangale is the president and sole shareholder of Union Cheese with responsibility for, and authority over, the management and day-to-day operations of Union Cheese. When Dominic Gangale is not present at the plant, defendant Annette Gangale assumes control of its operations.

On September 29 and 30, 1994 Food and Drug Administration ("FDA") Inspector Phillip M. Pontikos visited Union Cheese for the purpose of conducting a routine inspection. Pontikos testified to his observations on that date; his observations are memorialized in an Establishment Inspection Report (EIR) and FDA Form 483¹ prepared at the time of the inspection. Pontikos noted the following objectionable conditions relevant to the government's claims in this action:

1. There was a dead insect on top of a block of swiss cheese in brine solution.

2. In excess of 30 dead flies were floating throughout the brine solution while cheese was in the solution.

3. Dead insects too numerous to count with cob webs and dirt were on window sills in the brine room.

4. The dock door and main entrance door leading into the brine room were left open. The largest concentration of dead insects in the brine tank were located on the side next to the open doors.

5. A bearded employee was not wearing a beard cover while removing cheese from the brine solution.

6. There was no hot running water in the men and women restrooms in the brine room or in the sinks in the laboratory room.

7. Cheese scraps dropped on the floor in the cutting room were left for at least 2 hours.

Photographs taken of the conditions observed by Pontikos confirm his observations. Pontikos discussed his objections with Annette Gangale, who agreed with most of them and further agreed to discuss the problems with Dominic Gangale.

Pontikos collected two blocks of swiss cheese from Union Cheese on September 30, 1994 and submitted the samples to the FDA District Office in Cincinnati, Ohio for analysis. Jan Marie Hunt, a microbiologist with the FDA, testified that composite samples of each block were prepared (# 075) and the samples tested in accordance with the method set forth in the Bacteriological Analytic Manual developed by the FDA especially for testing cheese products.² One of the sub-samples tested positive for Listeria monocytogenes ("L. mono"). Union Cheese was notified of the finding and instructed to institute a recall and a subrecall (i.e. a notice to customers of the Union Cheese customer). The recall efforts undertaken by Union Cheese were incomplete because of poor coding on the cheese lots. Dominic Gangale admitted that he did not know to whom the contaminated cheese had been sold. As a result, the suspect cheese could not be traced.

On October 28, 1994 the FDA collected a cheese sample (# 408) from blocks sold to Fugazzi Cheese Co. in Cincinnati, Ohio. Tests were run on two composites. One subsample tested positive for L. mono. Union Cheese once again was instructed to undertake a recall. Dominic Gangale acknowledged that a broker for Union Cheese told Fugazzi that its cheese lots were not part of the recall.

On October 27 and 28, 1994 Pontikos made a limited inspection of the plant and collected 24 environmental swabs and 5 environmental samples from various areas throughout Union Cheese. The samples were sent to the FDA office in Cincinnati for testing. Because the environmental swabs used by Pontikos were outdated, the swabs were discarded. The environmental samples (# 443), however, were tested for L. mono and other listeria strains. L. mono was found in samples taken from liquid and flies from the brine tank as well as in material recovered from the floor next to a drain at the south end of the production room. Two other listeria species, listeria innocua and listeria grayi, were found in the floor material. During this inspection Pontikos found cheese which had been returned to Union Cheese because of mold. Of the 144 blocks of cheese returned, 44 showed mold. Annette Gangale told Pontikos that the mold would be cut off the end of the cheese and, after the cheese was tested for L. mono, the newly cut cheese would be repackaged for distribution.

On November 7, 1994 Pontikos conducted a follow-up inspection, collecting in-line (in production) and raw material samples (# 445) as well as environmental samples (# 444). With respect to the environmental samples L. mono was found on the outside surface of a wooden cheese box and in cheese trimmings from the floor. Listeria welshimeri was recovered from the floor in the cheese cutting area near a drain. Listeria innocua was recovered from the outside of the same wooden cheese box, the hands of an employee cutting cheese, a drain near a cheese cutter, the floor in the cheese cutting area near a drain, surfaces of a metal cheese cutter table, cheese trimmings and a drain near a cheese bagger. With respect to the in-line and raw material samples, L. mono and listeria innocua were found in raw milk in silo 1.

Pontikos and Steven Kilker, also an FDA Inspector, inspected Union Cheese on November 21, 1994 as a follow up on the recall process resulting from the discovery of L. mono in samples 408 and 443. At that time the inspectors were given copies of letters purportedly sent to Fugazzi Cheese Co. and Sysco/Continental in Indianapolis, Indiana, the consignees of the potentially contaminated cheese lots.

On November 29 — December 14, 1994 Pontikos, Kilker and Frederick Lochner, another FDA inspector, conducted an investigation of the plant. Their EIR states:

Current inspection found deviations from food GMP's Good Manufacturing Practices which relate to microbiological control. The firm relies on aging of the cheese since the milk is not pasteurized. Raw and finished operations are not sufficiently separate. The cutting room is not operated in a sanitary fashion to prevent contamination of cheese in cutting and packaging. The firm was found to be shipping cheese before the required 60 day aging was completed. Labeling for all products checked was missing all or some of the required elements.

The Form 483 lists the following conditions:

1. There was condensate dripping onto exposed cheese from the ceiling during cutting of cheese.

2. Paint on the ceiling directly above the cutting table was peeling.

3. Water temperature in the sink in the cutting room and restroom was 60-70 degrees.

4. No soap was available at the hand-washing sink in the cutting room.

5. The overhead door was left open during cheese cutting operations.

6. There are gaps along the side of the outside door near the cutting table and along the bottom of the door near the overhead door.

7. Hand cutting and scraping tools are not readily sanitizable (knives have wooden handles; some plastic handles have screws, nuts and washers; a rusty disposable knife with cheese residue on it is used for cutting through the wrapping on the blocks).

8. Cheese cutting tools are set on a table with a split surface on which "old product" is located.

9. The break area for employees and the restrooms are next to the brine tank where uncured cheese is handled. The employees who cut cheese walk through the brine tank room, through two dirty curtains and through an outdoor area to get to the cutting room.

10. Because the cutting area is in a separate building from the production area, the cheese taken from the brine room must pass through the outside to be cut.

11. Employee restrooms open directly onto the brine room. Handles on faucets are "very corroded."

Further, the inspectors noted the following objectionable employee practices:

1. Cutting tables are sanitized before rather than after breaks. Sanitizing fluid residue remains on the tables.

2. The employee who handles the wooden crates and drives the towmotor to the cooler for uncut cheese also unwraps and halves the cheese and handles exposed cheese without washing and sanitizing his hands.

3. Employees handling the cheese in cutting and packaging cheese did not wash or sanitize their hands over a period of several hours. They also returned from breaks without washing and sanitizing hands.

4. Halving of the cheese is done above or next to the floor drain, about 6 inches off the floor, on the pallet on which

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