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WARNING LETTER

Products Africana, Inc. MARCS-CMS 518173 —


Recipient:
Products Africana, Inc.


United States

Issuing Office:
New Jersey District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
New Jersey District Office
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054 

 

WARNING LETTER
 
May 9, 2017
 
VIA UNITED PARCEL SERVICE                                                                          17-NWJ-08
 
Mr. Christopher D. Ashie, Owner & President
Products Africana, Inc.
960 W. 7th Street
Plainfield, New Jersey 07063
 
Dear Mr. Ashie:
 
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 208 W. 3rd Street, Plainfield, New Jersey 07063 on January 10 through January 26, 2017. Our investigators found that you have serious deviations from Current Good Manufacturing Practice (CGMP) Regulations in Manufacturing, Packaging, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). In accordance with 21 CFR 110.35(a), failure to maintain buildings, fixtures, and other physical facilities of the plant, renders your food products 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). Accordingly, your fermented cornmeal products (Ga and Fanti Kenkey) and Hot pepper sauce with dried shrimp products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
 
In addition, we found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your fish and fishery are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
During this inspection, your significant violations were as follows:

Seafood HACCP:
 
1.    You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b).   However, your firm does not have a HACCP plan for Hot pepper sauce with dried shrimp (Shetor) to control the food safety hazards of Clostridium botulinum toxin formation; pathogenic bacteria growth and toxin formation; and undeclared major food allergens.
 
Current Good Manufacturing Practices (cGMPs):
 
1.    You must have instruments for measuring, regulating, and recording conditions that control or prevent growth of undesirable microorganisms that are adequate for their designated uses, as required under 21 CFR110.40(f). Specifically, your firm does not have any instruments to measure pH for your fermented cornmeal products (Ga and Fanti Kenkey) to ensure that the pH is at or below 4.6.
 
Your firm did not have information regarding the characteristics of the food products you manufacture, such as water activity (Aw), pH, and temperature. We have serious concerns about potential growth of spore and toxin forming bacteria, for example Clostridium botulinum and Bacillus cereus in the products.
 
2.    You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, during our inspection our investigators observed the following:
  • Two adult cockroach-like insects walking on the (b)(4) mixer during the production of Ga Kenkey (fermented cornmeal). Also, observed two cockroach-like insects in larvae stage nesting on an electrical cap on the mixer.
  • A live mouse on the second floor room where labels are cut and where Shetor Sauce is stored. Also, observed a dead mouse in a mouse trap with rodent excreta two numerous to count surrounding the mouse trap.
  • At least 12 fruit-fly-like insects were observed resting on the Ga Kenkey while it was waiting to be vacuum packaged in the manufacturing area.
  • Rodent excreta too numerous to count on an unused hopper that was staged in the processing area, underneath a sink in the processing area, and on an unused vacuum packaging machine. Also, observed three-rodent excreta on finished product cardboard boxes that were staged in front of the bay door prior to shipment.
  • Adult cockroach-like insects and larva were observed inside light bulbs located in the vents above the kettles used to (b)(4) Ga Kenkey.
  • Two dead cockroach-like insects on the (b)(4) mixer as it was mixing cornmeal and water for the production of Fanti Kenkey (fermented cornmeal).
  • Rodent excreta pellets too numerous to count underneath and behind the (b)(4) mixer as it was mixing cornmeal and water for the production of Fanti Kenkey.
  • Rodent excreta too numerous to count on an unused vacuum packaging machine stored in the production area.
  • Rodent excreta too numerous to count on unused baking trays and on the floor inside the utility closest.
  • Dead cockroach-like insects and bird excreta on pallets which were staged outside the facility.
3.    You must maintain buildings, fixtures, and physical facilities in repair sufficient to prevent your food products from becoming adulterated, as required under 21 CFR 110.35(a). However, during our inspection our investigators observed the following:
 
            Mold-Like Substance
  • Approximately a quarter of a square foot of a mold like substance in the corner of the ceiling of the production room where the Ga Kenkey product is weighed, rolled in banana leaves/corn husks, and wrapped in plastic food wrap.
  • Approximately three square feet of a mold like substance are on sheetrock wall surfaces in the   room where vacuum packaging of Ga Kenkey occurs. 
  • Approximately one foot long and six feet high of a mold like substance on a sheetrock wall behind a metal cart that was holding trays and cleaned utensils; that are used to manufacture and package Ga Kenkey products.  
  • Approximately one foot long and three feet high of a mold like substance on a sheetrock wall outside of the vacuum packaging area where finished products in cardboard shipping boxes are staged.
  • Approximately one square foot of a mold like substance on a sheetrock wall in an upper corner by the bay door where finished product is staged for shipment.
  • Approximately three feet long of a mold like substance a sheet rock wall above the bay door where finished product is staged for shipment.
  • Approximately two square feet of a mold like substance on the sheetrock wall surfaces behind the two-compartment-sink area used to wash equipment and utensils for manufacturing Kenkey products and Shetor Sauce. 
  • Approximately ten square feet of a mold like substance on the sheetrock wall surfaces underneath utility racks where (b)(4) holding fermenting cornmeal are stored.
  • Approximately three square feet of a mold like substance on the sheetrock wall surfaces underneath equipment which is used to cut corn husks.
  • Mold like substance inside the faucet and along the faucet’s fixture in the employee bathroom.   
            Holes in Walls and Chipping Paint
  • There was paint discoloration and chipping paint on the walls and ceiling beam in the production area where the Kenkey product is weighed, rolled in banana leaves/corn husks, and wrapped in plastic food wrap.
  • There is chipping paint on the door leading from the production area room to the manufacturing area where the Kenkey product is boiled.
  • The window sill from the production area to the vacuum packaging room was cracked and being held together with clear tape.
Employee Restroom Door
  • The employee bathroom is located within the production area where fermented cornmeal is wrapped in corn husks and banana leaves. The employee restroom door is not self-closing.
4.    You must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required under 21 CFR 110.80. However, during our inspection our investigators observed the following:
  • Your firm does not have a cleaning procedure or document any cleaning of equipment or utensils in your facility. Your employees were seen using a detergent but no sanitizer to clean equipment and utensils.
  • Your firm uses an all-purpose cleaning (b)(4) to clean-in-place the (b)(4) mixer; used to mix cornmeal dough to manufacture the products Ga Kenkey and Fanti Kenkey. No detergent or sanitizer was used to clean this (b)(4) mixer.
  • Your firm stored Frozen Banana Leaves, used to wrap the cornmeal for the product Fanti Kenkey, under ambient room temperature in the production area. The instructions on the product box states “Keep Frozen at -18ºC/0ºF”. 
  • Cornmeal dough was observed being weighed and rolled by your employees wearing either their street clothes or lab coats, which were not washed or cleaned on a periodic basis.
5.    You must use insecticides with necessary precautions and restrictions to protect against contamination of food and food-packaging materials, as required under 21 CFR 110.35(c). However, you perform your own pest control throughout the production facility where you see insects. Our investigators observed (b)(4) insecticide containers stored in the production area, where fermented cornmeal is weighed and wrapped.
 
6.    You must construct and handle equipment, containers and utensils used to convey food in a manner that protects against contamination, as required under 21 CFR 110.80(b)(7).  However, during our inspection our investigators observed the following:
  • Multiple cooking pots used to (b)(4) the Ga Kenkey and Fanti Kenkey products had excessive rust and corrosion on their interior surface. These pots were being used to manufacture Ga Kenkey and Fanti Kenkey.
  • Non-food-grade totes were used to store the cornmeal dough. The interior surfaces of the totes were rough with excessive scratches and gouges, and some of the totes had holes that were taped with clear packing tape and duct tape.
  • The handle on the knife used to cut Ga Kenkey and Fanti Kenkey products was completely wrapped in tape and the blade was rusty. The tool used to open raw ingredient containers was had excessive rusting and had tape completely around the handle.
  • The blue mat attached to the mixer used to prepare Ga Kenkey and Fanti Kenkey was encrusted with cornmeal dough and was fraying and pealing apart.
  • Trays used to hold Ga Kenkey and Fanti Kenkey had excess scratches and gouges and were black and discolored.
  • Black debris was observed on the interior of the (b)(4) mixture being used to mix cornmeal for the production of the product Fanti Kenkey.
7.    Your facility must be constructed in such a manner as to prevent drip and condensate from contaminating food and food-contact surfaces, as required under 21 CFR 110.20(b)(4). However, our investigators observed water condensate from the exhaust hood dripping directly onto the top of the cooking pots and two cooking lids. The exhaust hood is also encrusted with dirt and debris and the ceiling tiles above are not secured and observed to be bulging, which may contribute sources of contamination to the products being cooked below.
 
8.    You must have adequate drainage in areas which may contribute to contamination of food by seepage, foot-borne filth and providing a breeding place for pests, as required under 21 CFR 110.20(a)(3). However, during our inspection our investigators observed the following:  
  • There was pooling water approximately two inches deep and approximately six feet wide observed behind the gas stove and pooling water approximately one inch deep and three feet wide to the right of the gas stove used to (b)(4) the products Ga Kenkey and Fanti Kenkey.
  • There was pooling water approximately one-half inch deep and one-half foot wide in front of the mixer used to mix the cornmeal dough which is formed into Ga Kenkey and Fanti Kenkey.
  • There was pooling water approximately two-inches deep and two feet wide in front of the bay door where finished Ga Kenkey and Fanti Kenkey product is being held for distribution.
  • The surface of the driveway leading into the bay door is uneven and our investigators observed multiple puddles accumulating water in this area.
9.    You must provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required under 21 CFR 110.20(b)(1). However, our investigators observed 50 lb. bags of White Corn Meal stacked to the ceiling of the shipping container being stored in the parking lot outside your facility. There is not sufficient space to adequately inspect the floor-to-wall juncture in the shipping container for the presence of pests.
 
10.    You must remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required under 21 CFR 110.20(a)(1). However, our investigators observed pallets, debris, empty totes, metal racks, and leaves propped up against a  storage container that was located within approximately 20 feet of the bay door of the facility and within approximately 10 feet of the storage container storing cornmeal.
 
11.    You must properly hold and store toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food and food-contact surfaces, as required under 21 CFR 110.35(b)(2). However, our investigators observed dish detergent and chlorine bleach being stored next to Ga Kenkey product that was being (b)(4).
 
12.    You must provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). However,
  • There is a gap approximately two-inches high along the right side of the bottom of the bay door which leads into the manufacturing area of the facility.
  • There is a gap approximately one-inch high along its bottom of the entrance door which leads to the production area from the exterior of the facility. The door is not equipped with a screen door and it is not self-closing. 
Additional comments:
The egregious conditions observed at Products Africana, Inc. imply that the management and the workers lack a basic knowledge and understanding of food sanitation and hygiene practices and how to implement them.
 
The above violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all of your firm’s products are in compliance with federal laws and regulations. You should take prompt action to correct the violation cited in this letter. Failure to promptly correct the violation may result in legal action without further notice including seizure or injunction. You should within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violation including an explanation of each  step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot  complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
           
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 non-compliance materially related to a food safety requirement of the Act, specifically to determine 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. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
(b)(3)(A)
 
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
 
(b)(3)(A)
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
(b)(3)(A)
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10  Waterview Blvd., Parsippany, 3rd Floor, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer.
 
Sincerely,
/S/ 
Craig Swanson
Acting District Director
New Jersey District