- Porky's Gourmet Foods, Inc.
- Issuing Office:
- New Orleans District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
January 16, 2015
WARNING LETTER NO. 2015-NOL-04
UNITED PARCEL SERVICE
Delivery Signature Requested
Ronald P. Boyle, President
Porky’s Gourmet Foods, Inc.
644 N Blythe Avenue
Gallatin, Tennessee 37066-2226
Dear Mr. Boyle:
During November 20, 21, 25 and December 2, 2014, United States Food and Drug Administration (FDA) investigators inspected your sauce and dry spice blend manufacturing facility, located at 644 N Blythe Avenue, Gallatin, Tennessee. This inspection found your firm manufactures a variety of sauces and dry spice products including, but not limited to, barbecue sauce and seasoning products. The inspection determined you have significant deviations from the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations
, Part 110 (21 CFR 110). These violations cause the food products manufactured in your facility to be adulterated within the meaning of Section 402(a)(4) of the Act, [21 United States Code
(USC) 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and the LACF regulations through links in FDA’s website at www.fda.gov.
Our investigators provided you with a Form FDA 483, Inspectional Observations, at the close of the inspection on December 2, 2014. A copy of the Form FDA 483 is enclosed for your reference. Violations revealed during the inspection include, but are not limited to, the following:
1) You must take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pest, in accordance with 21 CFR 110.35(c). Specifically, apparent rodent excreta pellets (aREPs) and apparent insects were observed in the following locations within your manufacturing facility:
a) At least two aREPs were observed on the floor along the west wall, approximately 16" south of the northwest corner of the production area, adjacent to a pallet holding plastic jugs of an unlabeled liquid and a plastic bucket of (b)(4)
b) At least eight aREPs were observed on the floor in the northeast corner of the production area adjacent to two pallets on the floor holding various paper bags of dry spice ingredients, including (b)(4) brand barbecue seasoning, sauce spice, and citric acid anhydrous.
c) At least 40 aREPs were observed on the floor along the east wall behind the aforementioned pallets of dry spice and metal ingredient holding shelf. These aREPs were observed after removal of approximately 13-4’ x 8’ sheets of drywall and two 4’ x 8’ sheets of plywood which were stored along the wall behind the ingredient shelf.
d) Apparent dead insects, too numerous to count, were observed on the floor along the east wall under and around the pallets holding dry spice ingredients in the production area. Additionally, apparent dead insects were observed on the floor along the walls in numerous locations of the production area.
e) At least two live winged insects and at least ten dead apparent insects were observed on and within a folded and taped paper bag holding (b)(4) raw ingredient which was stored on a pallet within the warehouse area. Additionally, numerous apparent dead insects were observed on the floor in multiple locations within the warehouse area.
Our Investigator observed you voluntarily destroyed the (b)(4) during the inspection.
2) You must provide adequate screening or other protection against pest, in accordance with 21 CFR 110.20(b)(7). Specifically, unscreened openings and gaps large enough to allow for ingress of pests were observed in the following areas:
a) A floor drain pipe located approximately three feet west of the sauce filler and leading directly to the north exterior of the facility was partially unscreened. The plastic cleanout cap for the drain line, which was located on the ground at the north exterior of the facility, was broken and created direct access from the exterior of the facility to the production area.
b) A gap, approximately 7" x 3/4", between the floor and the damaged bottom right side of the dock door along the south wall in the food and food packaging warehouse.
c) A gap, approximately 2' x 3/4", between the roll down door and the wall along the right side of the dock door along the north wall in the food and food packaging warehouse.
d) A gap, approximately 3/4", between the deteriorated concrete floor and the dock door along the entire length of the center dock door located along the south wall in the non-food section of the warehouse.
e) A gap, approximately 14" x 1", between the floor and the damaged bottom right side of the east dock door along the south wall in the non-food section of the warehouse.
f) A gap, approximately 1' x 6", in the ceiling near the ridge in the center of the west wall of the non-food storage warehouse.
g) A hole, approximately 8" x 5", in a cinder block about 10" above the ground located on the east exterior wall, north of the main office entrance adjacent to rodent bait station #1.
h) A hole, approximately 5" x 3", in the metal siding directly behind the air conditioning unit along the east exterior wall. The hole was made for the air conditioner condensing unit coolant line. Apparent nesting material was observed in this hole.
i) An unscreened pvc pipe was observed extending from the concrete slab located along the north exterior wall. The pipe appeared to lead directly into the facility.
3) You must clean food-contact surfaces as frequently as necessary to protect against contamination of food, in accordance with 21 CFR 110.35(d). Specifically, the interior of the plastic transfer tubes and metal ends of the spice filler appeared soiled and discolored with adhering spice immediately prior to filling of barbecue seasoning on November 25, 2014. The underside framing of the spice filler was also observed with adhering product.
During the inspection, we noted that you cleaned the transfer tubes of the spice filler; however, it remained discolored.
4) You must install and maintain manufacturing equipment as to facilitate its cleaning and of all adjacent spaces, in accordance with 21 CFR 110.40(a). Specifically, the bottle loading turntable for the bottling line was observed to have bumpers wrapped with paper towels and secured with box tape which appeared soiled and not easily cleanable. In addition, the food grade hose used to transport bulk liquid ingredients to the cook kettle is damaged in such a way that it is partially crimped with two broken and rusty helical wire supports protruding from the hose.
5) You must clean and sanitize equipment in manner that protects against contamination of food, in accordance with 21 CFR 110.35(a). Specifically, the following areas in the production room were observed in insanitary conditions:
a) The metal piping of the sauce filling tubes had areas of adhering product which appeared to be leaking from the connection between two pipes.
b) The framing of the bottling line prior to the capping equipment appeared soiled with adhering product, hair, dust, and debris.
c) Spider webs and a layer of dust on the wood 2’ x 4’s and drywall immediately behind and adjacent to the shelf holding ingredients along the east wall.
d) Apparent mold/mildew and staining on the floor and baseboards along the north wall of the production area immediately adjacent to finished packaged product.
6) You must use insecticides or rodenticides under precautions and restrictions that will protect against the contamination of foods, food-contact surfaces, and food-packaging materials, in accordance with 21 CFR 110.35(c). Specifically, unlocked bait stations containing rodenticide and an open package of rodenticide were observed on the floor of the warehouse holding raw ingredients.
7) You must construct your facility in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and in good repair, in accordance with 21 CFR 110.20(b)(4). Specifically, the following structural deficiencies were noted within your facility:
a) The metal siding along the south wall was pulled away from concrete floor leaving a gap of approximately 2' x 6" with direct access into the food and packaging storage warehouse from the exterior. The gap was immediately adjacent to plastic packaging caps and within two feet of stored food.
b) The majority of the floor of the production room was in a state of disrepair with flaking paint. Loose paint flakes were observed throughout the production area.
c) The insulated vinyl-type ceiling cover in the production area and the warehouse was observed with numerous tears. Several tears were patched with duct tape. The tape was observed loose and hanging down in areas such as directly over the cook kettle, the sauce filler, and the bottling line.
d) A large hole, approximately 10" x 6", in the wall below the three compartment sink where the drain pipe extends into the wall.
8) You must provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, in accordance with 21 CFR 110.20(b)(1). Specifically, the following food and non-food storage areas were observed to be cluttered in such a way as to prevent thorough cleaning and inspection for pests:
a) The storage area along the east wall east of the three compartment sink in the production area was cluttered with items such as empty plastic buckets, boxes of light bulbs, and food grade transfer hoses.
b) The area of the floor in in the southeast corner of the production area adjacent to the small item delivery door was cluttered with non-food use items such as wood, a shovel, large chain, hose, post driver, tarp, and air compressor.
c) The warehouse storage area located on the west side of the facility was observed to be extremely cluttered with unused food service equipment and items not essential for the production of food including, but not limited to: a Lear jet; a stuffed black bear; musical instruments; multiple household items; and at least 12 stacks of unused pallets. Most of the items were positioned in such a way as to prevent the proper cleaning and inspection of the perimeter. This storage area is open to the raw materials, packaging, and finished food storage area with direct access to the production area through a large sliding door which did not fully close.
d) The warehouse storage area adjacent to the finished product storage in the northeast corner of the warehouse was cluttered with unused food service equipment, household items, and empty raw ingredient packaging material.
9) You must store raw materials in a manner that protects them against contamination and minimizes deterioration, in accordance with 21 CFR 110.80(a)(1). Specifically, the following raw ingredient food products were observed stored in your facility in leaking, damaged, and/or deteriorated packaging or had exceeded its shelf life:
a) Four cans of (b)(4) brand whole kernel corn, which contained at least one leaking can.
b) Various products in cans located on a pallet, including two cans of (b)(4) brand crushed tomatoes, were swollen and contained rust on the top seam.
c) Five-one gallon plastic jugs of (b)(4) were stored in leaking containers and with visible mold on the interior of the cardboard case.
d) Two-one gallon plastic bottles of (b)(4) were stored in leaking containers.
e) Four cans of (b)(4) were rusted and deteriorated.
f) One case of (b)(4) contained leaking cans
g) Three cases of (b)(4) showed signs of leaking with visible mold on the outside of the case.
h) One approximately 55 gallon plastic barrel of (b)(4) was leaking with food debris and mold on the floor under and around the barrel.
i) One case of (b)(4) was observed with an expiration date of July 17, 2012.
j) One case, consisting of five 32 ounce cartons of (b)(4) showed signs of leaking and deteriorating packages. The product was observed in the non-functioning freezer at ambient temperatures.
Our investigator observed you destroyed the following items during the inspection:
• One case, consisting of 4-#10 cans of (b)(4) brand whole kernel corn
• At least 15-#10 cans of various products on a pallet, including two cans of (b)(4) brand crushed tomatoes
• Five-one gallon plastic jugs of (b)(4)
• Two-1gallon plastic bottles of (b)(4) stored in leaking containers
• Four-#10 cans of (b)(4)
• Six-#10 cans of (b)(4) in leaking cans
• At least six cases of (b)(4)
• One approximate 55 gallon barrel of (b)(4)
• One case of (b)(4)
10) You must properly store equipment, remove litter, and remove waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, in accordance with 21 CFR 110.20(a)(1). Specifically, three large pieces of spice blending equipment on broken pallets and a large tarp were observed stored on the ground immediately adjacent to the north side of the exterior of the facility near the northeast corner. In addition, a condensate drain pipe leading from the boiler was depositing water onto the ground under the wood deck/dock area. The drain pipe created a pool of standing water.
11) You must adequately maintain instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms, in accordance with 21 CFR 110.40(f). Specifically, the buffer used for calibrating your pH meter which is used to insure all finished product sauces are below pH 4.6 expired in May 2007.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is also your responsibility to assure not only the current objectionable conditions are corrected, but appropriate policies and procedures are implemented to prevent recurrence of the problems. You should take prompt action to correct these violations. Failure to make corrections could result in regulatory action without further notice. Possible actions include, but are not limited to, seizure and injunction.
You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violation, including an explanation of each step taken to prevent the recurrence of a similar violation. At the conclusion of the inspection, we noted you promised to correct the objectionable conditions noted on the Form FDA 483. You may wish to include in your response documentation that would be useful in assisting us in evaluating your corrections. If you cannot complete all corrective action before you respond, we expect that you will explain the reason for your delay and state when you will correct remaining deficiencies.
Section 743 of the Act, [21 USC 379j-31], authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the above address. If you have questions, concerning the contents of this letter, you may contact Mr. Rivero at (504) 832-1290, extension 1103.
Ruth P. Dixon
New Orleans District