Inspections, Compliance, Enforcement, and Criminal Investigations
United Metro Distribution Co.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207
September 10, 2009
RETURN RECIPT REQUESTED
Mr. Tak M. Lee, Owner
United Metro Distribution Company
65 S. Forest Avenue
Indianapolis, IN 46201
Dear Mr. Lee:
The Food and Drug Administration (FDA) conducted an inspection of your food distribution company located at 65 South Forest Avenue, Indianapolis, IN 46201 on May 15, 18-19, 22, and 27, 2009. Our inspection found significant deviations from the Current Good Manufacturing Practice (CGMP) requirements for holding human food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products manufactured at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the regulations through links in FDA's homepage at www.fda.gov.
Your significant violations are as follows:
1. Failure to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required under 21 CFR 110.35(c). Our investigators observed the following during the inspection;
A. Live mice were present behind and between lots of stored food items in three locations; live birds were present near stored rice, fortune cookies, and sugar in two locations; and live and dead flies were present around bags of onions in two locations,
B. More than 100 rodent excreta pellets (REPs) and two apparent rodent gnawed holes were found on a pallet of (b) (4). REPs were present on the surface of the pallet, around the pallet base, and on the surrounding floor.
C. One pallet of individually-wrapped fortune cookies contained a partially opened box with 20 packages that were rodent gnawed; one of the packages contained an apparent REP. Twenty-five REPs were present in the bottom of this box. Fifteen apparent REPs were present on the surface of a second pallet and inside the plastic wrap surrounding it.
D. In a lot of (b) (4) potato starch in 44 lb. bags, two bags with gnaw holes and 30 REPs were present on one pallet; one bag with a gnawed hole and three REPs were present on a second pallet, and six gnawed holes on bags and eleven apparent REPs were observed on a third pallet.
E. In a lot of 15 pallets of 100 Ib bags of (b) (4) Extra Fancy Long Grain Rice, seven apparent REPs were present on the surface of the bags and surrounding shrink wrap. A second pallet had one bag with a gnawed hole, and four apparent REPs were present between the shrink wrap and bags.
F. On a mixed pallet of flour and salt, two bags of flour had nineteen apparent REPs mixed in or around the spilled flour from two apparent gnawed holes in one bag.
G. On a pallet of 25 lb bags of (b) (4) Wheat Flour, Lot #0415910807, one bag had an apparent gnawed hole and one apparent REP in the product. A second bag on this pallet also had one apparent gnawed hole with 25 apparent REPs on the bag top near the seam.
H. In lot # DW9D580AL of (b) (4) cornstarch, two bags had one apparent gnawed hole and a third bag had two apparent gnawed holes.
I. Three dead birds were present in bird netting in the middle warehouse area, near exposed packaging materials and bird droppings were too numerous to count.
We acknowledge your voluntary disposition of various products during the inspection. In your June 11, 2009, response to the FDA Form 483, 1nspectional Observations, you state that you are working with your pest control company to mass trap the rodents and birds in your facility. Trapping is a corrective action you have used in the past according to evidence collected by our investigators. However, this does not appear to have prevented recurrence of this problem. We are concerned about any rodents that may be living in areas of your plant where they are not easily trapped, such as your dropped ceiling areas. Please address this concern and detail how the planned trapping you are doing now differs from past uses of this method to prevent recurrence.
2. Failure to maintain buildings in repair sufficient to prevent food from becoming adulterated, as required under 21 CFR 110.35(a). Our investigators observed the following deficiencies during the inspection:
A. The four dock doors and middle personnel entrance door had large gaps present (approximately 3" in height) along the bottom while closed.
B. A hole approximately 3" wide was located in the southwest corner office area with more than 100 REPs near the hole.
C. Two holes approximately 1" wide were located in two separate window panes on the north wall next to bagged product.
D. The door to the freezer used to store shrimp had a damaged frame preventing proper closure.
E. The drop ceiling in the southwest corner office area had a large hole approximately 5" in diameter.
F. Water dripped from the roof in two locations of the middle portion of the warehouse near stored products.
G. A ceiling tile in the rack storage area above the storage area for bagged products, such as rice and corn starch, contained an 8" hole.
In your June 11, 2009 response to FDA Form 483, Inspectional Observations, you state that the dock doors were replaced on June 4, 2009. You also state that the hole observed in the office area was repaired. Your response also states that the personnel door will be closed as much as possible, but you do not address the gap our investigators observed beneath this door. You also state that the holes in the window panes were covered, but you do not state how they were covered and if this was a permanent repair. Finally, your response states that the observed holes in the ceiling tiles appear to be caused by dripping water from leaks in the roof that will require additional time to repair. Please provide information on how you plan to repair the personnel door to prevent entry of pests, how the windows were covered, and a time frame on when the roof repair will be completed.
3. Failure to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of your plant facility that may constitute an attractant, breeding place, or harborage area for pests, as required by 21 CFR 110.20(a)(1). Specifically, our investigators observed the following:
A. A file cabinet, table and various other office equipment were present on the outside of the warehouse along the south side of the warehouse.
B. A large pile of tree branches and wood logs were present at the rear of the facility across from the east side. Also wood boards, bricks, pipes and a plastic cover were present on the ground near the south dock door.
C. Two large dumpsters, one overflowing with trash and one lacking a lid, were located across the parking lot on the west side of the facility during each day of the inspection. Other trash items such as boxes and office furniture were present around both dumpsters.
D. The surrounding lawn on the south, east and north sides of the warehouse was over grown to approx. 1' in height.
E. A plastic freezer curtain was folded in a corner mixed with five pieces of wood and cement brick on the floor next to the North door of the freezer used to store shrimp.
Regarding deficiencies identified in the immediate vicinity of your facility, your June 11, 2009, response appears to be adequate and will be verified during a subsequent inspection. However, you have been cited for similar observations in past FDA and State inspections and any corrective actions from those inspections do not appear to have solved this problem long term. It is your responsibility to maintain your surrounding grounds to prevent harborage of pests that may gain entry to your facility.
Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
You should notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator, actions performed to control the unauthorized entering of pests, plans on how you plan to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and include a timetable for the implementation of any remaining corrections.
Your written response should be sent to LCDR Anastasia M. Piliafas-Brown, Compliance Officer, U.S. Food and Drug Administration; 300 River Place, Suite 5900, Detroit, Michigan 48207; If you have any questions about this letter, please contact Compliance Officer Piliafas-Brown at (313) 393-8100 Ext. 8270.
Joann M. Givens
Detroit District Office