|Company:||Sam & Son Wholesale Group, Inc.|
|Subject:||CGMP Regulation for Foods/Adulterated|
|Issuer:||Atlanta District Office|
|Issued:||Aug. 31, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Atlanta District Office
August 31, 2012
Kwang Woung Choi, Owner
Sam & Son Wholesale Group, Inc.
290 University Avenue SW
Atlanta, GA 30310
Dear Mr. Choi:
On June 5-18, 2012, investigators of the U.S. Food and Drug Administration (FDA) conducted an inspection of your multiple food storage facility, located at 290 University Avenue SW in Atlanta, GA. FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, found in Title 21 of the Code of Federal Regulations Part 110 (21 CFR 110). The violations, which include evidence of rodent activity, render the products held at your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 United States Code (U.S.C) § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and pertinent FDA regulations through links on FDA’s website at www.fda.gov .
The serious CGMP violations noted during the inspection were outlined on a FORM FDA 483, Inspectional Observations, issued to Helen P. Choi, Manager, at the close of the inspection. Those violations include the following:
1. You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). Specifically, on 6/13-15/2012, FDA investigators observed rodent gnaw holes and rodent excreta pellets on finished products, and live birds in your food storage facility. For example, during a bag-by-bag examination of dog food, four (4) rodent gnaw holes and seven (7) rodent excreta pellets were observed on the bags. Furthermore, three (3) of the four (4) rodent gnaw holes extended through the packaging material to the product. Also, investigators observed live birds flying in and out of your food storage facility through broken windows in the cooler and freezer areas.
2. You failed to ensure that your plant and facilities were constructed in such a manner that drip and condensate from fixtures, ducts, and pipes does not contaminate food, food contact surfaces, or food-packaging materials, to comply with 21 CFR 110.20(b)(4). Specifically, on 6/5/12, FDA investigators observed condensate dripping from the overhead freezer units, causing ice buildup on boxed French fries, vegetables, and fish in the freezers. Condensate was also observed in the cooler, dripping onto cases of milk. Also, turnip greens, hanging over the wooden pallet on which they were stored, were observed to come into contact with condensate that had pooled on the floor. Furthermore, there were at least ten (10) additional areas in the cooler where condensate was observed dripping and pooling on the cooler floor.
3. You failed to ensure that your plant and facilities are constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair, to comply with 21 CFR 110.20(b)(4). The floors, walls, and ceiling of your food storage facility were observed to be severely damaged. Among the observations noted were the following:
• Over ten (10) roof leaks and ceiling holes, with exposed insulation, throughout your facility, resulting in damaged and wet food products and food storage containers;
• One (1) major roof leak was observed in the cooler, with water pouring directly onto the cooler floor;
• Eroded concrete floors were observed throughout the warehouse, including the floors in the cooler and freezers containing large cracks with standing water;
• A section of the warehouse floor was observed with an approximate 3ft x 3ft hole exposing dirt.
4. You failed to store finished food under conditions that will protect the food against physical, chemical, and microbial contamination, as well as, against deterioration of the food and the container, to comply with 21 CFR 110.93. The following are among the objectionable observations observed during the inspection:
• Over 15 pallets of a juice drinks were observed with mold due to previous water damage,
• Food items, including flour and dog food, were observed to be damaged and stored open to the environment,
• Previously damaged packages of flour were found taped and stored among other products intended for distribution;
• Overturned cases of frozen tilapia fillets were observed, allowing the fillets to come into direct contact with the ice room floor; and
• In the cooler, old strip curtains were observed to be stored on top of drinks with caps that come into direct contact with the consumer’s mouth.
5. You failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, to comply with 21 CFR 110.20(a)(1). The following are among the objectionable conditions observed during the inspection:
• Bushes, small trees, large weeds, and vines were observed throughout the outer perimeter of your facility and in close proximity to the building;
• Old equipment, trash, old wood and plastic pallets, and other large debris were observed around the perimeter of your facility;
• Numerous grocery carts, stored among trash and weeds were directly against the building;
• Unused semi-trailers and discarded cardboard containers were stored in close proximity to the facility.
6. You failed to provide adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). Specifically, the following observations were among those observed during the inspection:
• An approximate ¼ in x 2 ft gap along the side of an emergency exit door on the West side of the building;
• An approximate 3 in x 2 in hole in the top of the North exterior wall with insulation exposed;
• The loading dock door was open throughout the inspection when not in use.
7. You failed to provide your employees with adequate, readily accessible toilet facilities that are maintained in a sanitary condition, to comply with 21 CFR 110.37(d)(1). Specifically, FDA investigators observed two employee bathrooms to be kept in an insanitary condition with trash, toilet paper, cardboard, and other items stored in the handicap stalls and throughout the bathrooms. Furthermore, there was no soap and sanitary towel service available for hand washing.
8. You failed to provide safety-type light bulbs over exposed food to protect against food contamination in case of glass breakage, to comply with 21 CFR 110.20(b)(5). Specifically, you did not have shields or safety lights installed in your warehouse, freezers, and cooler, where exposed food items such as fresh produce are stored.
9. You failed to provide facilities with sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations, to comply with 21 CFR 110.20(b)(1). Specifically, food and food-related items were observed stored directly against the wall in your facility, which prohibits inspection for pest control and sanitation purposes.
We acknowledge that your firm initiated corrective actions prior to the close of the inspection to correct some of the objectionable observations noted. For example, we are aware that you voluntarily destroyed several damaged and expired food items. You reconditioned four (4) pallets of dog food found with rodent gnaw holes and rodent excreta pellets. We acknowledge that you repaired some of the noted roof leaks and the hole in the floor. Although these corrective actions address in part some of the violations noted during the inspection, we have not received a written response from you outlining the steps you have taken to address all of the objectionable observations, including identifying the root causes to prevent reoccurrence of the violations or the occurrence of additional ones.
This letter nor the FORM FDA 483 is intended to be an all-inclusive statement of the violations that exist at your firm. A copy of the FORM FDA 483 is enclosed for your review. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act and pertinent FDA regulations. You should take prompt actions to correct the violations cited in this letter. Failure to promptly and adequately correct these violations may result in FDA initiation of regulatory actions, but not limited to, seizure of your products or injunction.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determining whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or plan to take to correct the current violations and prevent similar ones. Include the timeframe within which the corrections will be completed and documentation that will effectively assist us in evaluating the adequacy of the corrections, such as photographs. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
John R. Gridley
FORM FDA 483, dated 6/5-18/2012