United States v. Chung's Prods. LP
| Decision Date | 04 April 2013 |
| Docket Number | CIVIL ACTION NO. H-10-759 |
| Parties | UNITED STATES OF AMERICA, v. CHUNG'S PRODUCTS LP, et al, Defendants. |
| Court | U.S. District Court — Southern District of Texas |
Pending before the Court is the Government's Motion for Summary Judgment (Doc. 16), as well as Defendants Chung's Products, LP, Charlie A. Kujawa, and Gregory S. Birdsell's response (Doc. 30), the Government's reply (Doc. 34), Defendants' surreply (Doc. 38), the Government's response thereto (Doc. 41), Defendants' supplemental declaration (Doc. 47), and the Government's response thereto (Doc. 50). Upon review and consideration of this motion, the response, replies, and surreplies thereto, the relevant legal authority, and for the reasons explained below, the Court finds that the motion should be granted.
This is a statutory injunction proceeding brought under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 331 et seq.
Defendant Chung's Products, LP ("Chung's") operates a food processing facility at 3907 Dennis Street in Houston, Texas. (Doc. 1 at 2.)
Defendant Charlie A. Kujawa ("Kujawa") is president of operations at Chung's. (Doc. 16, Exh. 2.) Kujawa represented Chung's at a regulatory meeting with Federal Drug Administration ("FDA") officials on March 6, 2008. (Doc. 16, Exh. 2C.) During the most recent inspection by the FDA in June 2009, Kujawa identified himself as the "most responsibleperson"1 at Chung's facility. (Doc. 16, Exh. 1.)
Defendant Gregory S. Birdsell ("Birdsell") was the director of quality assurance at Chung's. (Doc. 30, Exh. 2.) Birdsell also represented Chung's at a regulatory meeting with the FDA on March 6, 2008. (Doc. 16, Exh. 2C.) Along with Kujawa, Birdsell was the point-of-contact for FDA investigators during the two most recent inspections. (Doc. 16, Exh. 1.) Birdsell has since left Chung's, and Eddy T. Lee is now the director of quality assurance. (Doc. 50 at 1.)
Chung's facility falls under the dual jurisdiction of the U.S. Department of Agriculture ("USDA") and the FDA. (Doc. 30 at ¶ DJ1.) Chung's manufactures vegetable and shrimp egg rolls, which are regulated by the FDA, as well as chicken and pork egg rolls, which are regulated by the USDA. (Doc. 16, Exh. 1.) Chung's also imports prepared shrimp spring rolls from China, which it sells under the Chung's brand name. (Id.)
The FDA inspected Chung's facility in 2005, 2006, 2007, and 2009, documenting sanitation conditions and verifying food safety records. (Doc. 16, Exhs. 1H, 1G, 1D, 1B.) After each inspection, the FDA investigator issued observations on an FDA Inspectional Observation Form 483 ("Form 483"). (Id.) Each Form 483 documented numerous observations of noncompliance regarding sanitation practices and monitoring of food safety hazards. (Id.) The investigator discussed each of these observations with Birdsell and Kujawa during meetings prior to the issuance of the forms. (Id.) In addition, the FDA held meetings with Chung's following the 2006 and 2007 inspections. (Doc. 16, Exh. 2E, 2C.)
On October 30, 2007, the FDA issued a warning letter to Chung's citing "significant violations" of the FDCA and food safety regulations under. (Doc. 16, Exh. 2A.) Chung's sentwritten responses to each violation and observation made at the four inspections and requested two meetings with FDA officials. (Doc. 30, Exh. A4 at 2.) Chung's says all issues were promptly resolved. (Doc. 4 at 2.) The Government alleges that despite "multiple warnings by the FDA, Defendants have demonstrated either inability or unwillingness to develop and implement adequate sanitation measures and an appropriate [Hazard Analysis Critical Control Point] plan to control the risk of microorganisms in their food." (Doc. 1 at 9.) The Government concludes that "[b]ased on their repeated course of conduct, Defendants will continue to violate 21 U.S.C. §§ 331(a) and (k) unless restrained by order of this Court." (Doc. 1 at 9.)
During each inspection of Chung's facility, the FDA documented recurrent sanitation concerns, including the use of unsanitary hoses, condensation problems, and poor employee hygiene. (Doc. 16, Exhs. 1H, 1G, 1D, 1B.)
At the 2005 inspection, the FDA investigator observed employees using filthy hoses "sitting in 6 inches of water" on the floor to clean a vegetable grinder and fill a tank of shrimp by submerging the hose in the tank. (Doc. 16, Exh. 1H.) At the 2007 inspection, the investigator again observed an employee on multiple occasions picking a hose off the floor to "either wash down equipment or fill the hand dip buckets or white 55 gallon barrel with water" used for moistening egg roll wrappers. (Doc. 16, Exh. 1D.) In April 2010, the Defendants' expert witness, Dr. Leslie Bluhm ("Bluhm") observed similar acts during his inspection. (Doc. 30, Exh. C at 4.)
At the 2005 inspection, the investigator also observed condensation dripping from an air conditioning unit to the floor near egg roll filling ingredients. (Doc. 16, Exh. 1H.) Condensation was again observed dripping from multiple air conditioning units in 2007. (Doc. 16, Exh. 1D.)One unit leaked "directly over the final product conveyor belt." (Id.) Two other air conditioners leaked above ingredients in the filling room and "[c]ondensate was observed dripping into the shrimp egg roll filling." (Id.) In 2009, the investigator observed an accumulation of ice and debris, including discarded egg rolls on the floor of a freezer where finished egg rolls were stored. "According to Mr. Birdsell[,] the air-conditioning system had a leak and the ice formed due to the leak." (Doc. 16, Exh. 1F at 35.) The investigator also observed an "oily brown substance" running down the length of the wall of the refrigerator near raw egg roll wrappers and a "black, mold-like substance" on a shelf where raw chicken and onions were stored. (Id.)
At the 2005 inspection, the investigator observed employees handling garbage and then processing vegetables without washing their hands. (Doc. 16, Exh. 1H.) Again, at the 2007 inspection, the investigator reported that employees were handling bins of egg roll filling after using a floor squeegee without washing their hands. (Doc. 16, Exh. 1D.) One employee rinsed his hands in the water used for dipping the egg roll wrappers. (Id.) After the 2007 inspection, Chung's responded to these problems by conducting "on-site training of line workers in proper sanitation and personal hygiene practices." (Doc. 30, Exh. A8 at 2.) At the 2009 inspection, the investigator observed Defendant Birdsell not covering his beard with a beard net in the mixing room, as required by 21 C.F.R. § 123.11(b)(6) as well as by Chung's sanitation policy. (Doc. 16, Exh. 1F at 34.) Birdsell was "responsible for providing [sanitation practices] training" at Chung's. (Doc. 30, Exh. A17 at 8.)
The Government alleges Birdsell and Kujawa failed to cooperate with FDA investigators in providing sanitation records. The parties disagree whether Chung's properly disclosed its sanitation records during the 2009 inspection. The investigator reported:
Mr. Kujawa and Mr. Birdsell would not provide all of the firm's sanitation records during the inspection. After several requests and a great deal of discussion . . . Mr. Birdsell explained that if I could name the document or identify the specific documents that I wished to see he would gladly provide them. . . . Mr. Birdsell was not willing to provide all the necessary sanitation records since I did not identify them by their individual title or document name. I specifically asked for the firm's records that covered the eight items of sanitation that are required to be maintained by a firm that manufactures seafood products.
(Doc. 16, Exh. 1F at 38.) Kujawa testified:
In my presence, Mr. Birdsell . . . asked [the investigator] exactly what information he needed so that we could point it out to him and show him precisely where each required sanitation element was contained in our documentation and programs but [the investigator] was not able to define what he wanted to see.
(Doc. 30, Exh. A at 23.) Chung's gave the investigator documents containing its Sanitation Standard Operating Procedures ("SSOPs") and sanitation checklists for certain dates. (Doc. 30, Exh. A17 at 10.) SSOPs are recommended practices, not records of observations. 21 C.F.R. § 123.11. The checklists contained lists of sanitation items. (Id.) Next to each item was an "A" for "Accept" and an "R" for "Reject." Twice a day, an employee was to examine each item and circle the appropriate letter. (Id.) The items on Chung's sanitation checklists do not correspond to the eight requirements for Sanitation Control Records:
+-----------------------------------------------------------------------------+
¦Required Sanitation Control Records (21 ¦Chung's Sanitation Checklists (Doc.¦
¦C.F.R. § 123.11) ¦30, Exh. A17) ¦
+-----------------------------------------+-----------------------------------¦
¦ ¦A. Preoperational Checklist ¦
¦(1) Water safety ¦ ¦
¦ ¦(1) Equip. ¦
¦(2) Cleanliness ¦ ¦
¦ ¦(2) Walls ¦
¦(3) Prevention of cross-contamination ¦ ¦
¦ ¦(3) Floors ¦
¦(4) Handwashing, toilet facilities ¦ ¦
¦ ¦(4) Ceiling ¦
¦(5) Control of food contaminants ¦ ¦
¦ ¦B. Operational Checklist ¦
¦(6) Control of toxic chemicals ¦...To continue reading
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