Mr. Leonardo C. Morales
- Cracker King Corp.
307 Peninsula Blvd
Hempstead, NY 11550-4912
- Issuing Office:
- New York District Office
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Office of Human and Animal Food Operations East
UNITED PARCEL SERVICE
Mr. Leonardo C. Morales, President
Cracker King Corp.
307 Peninsula Blvd
Hempstead, NY 11550-4912
Dear Mr. Morales:
The U.S. Food and Drug Administration (FDA) inspected your cracker manufacturing facility located at 307 Peninsula Blvd, Hempstead, NY 11550-4912, on June 7, June 8, June 15, and June 20, 2017. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 [21 CFR Part 110].
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions in your facility at the time of the inspection. Failure to manufacture foods in accordance with the CGMP requirements in 21 CFR Part 110 renders your firm's 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)], 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 heath.
You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov
We acknowledge receipt of your email correspondence on June 22, 2017, June 23, 2017, July 14, 2017 and July 19, 2017 in which you provided a response to Form FDA-483, Inspectional Observations. Our comments concerning your response are noted below.
Your significant violations are as follows:
1. You must perform filling, assembling, packaging, and other operations in such a manner that protects food from becoming contaminated, as required by 21 CFR 110.80(b)(13). Your firm manufactures products which contain egg and soy products; however, you have no allergen control program in place, such as scheduling production based on allergens, having dedicated equipment, or effectively cleaning between your products.
Your email responses do not address this observation.
2. Your firm failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically, on 06/08/2017, our investigator observed food debris and food dust on the following food contact surfaces of your automated packaging line even after cleaning was completed on 06/07/2017 following the production of egg-containing crackers:
a. In the corners and along the edges of the large stainless steel, rectangular hopper where the baked crackers are first staged before entering the packing line.
b. In the corners and along the bottom of the plastic-type conveyor belt that transfers the baked crackers from the first hopper and into the second stainless steel, rectangular hopper where the baked crackers are again staged before entering the second conveyor system.
c. In the corners/edges of the plastic-type buckets of the bucket elevator that is used to lift the baked crackers from the second hopper and up to the shoot.
d. On the top stainless steel surface of the sorter where the baked crackers are sorted into the sixteen filling heads.
e. Inside each of the stainless-steel filling heads where the baked crackers pass prior to being dropped down into their bags.
Your email responses do not address this observation.
3. The design, materials, and workmanship of equipment does not allow for adequate cleaning and proper maintenance, as required by 21 CFR 110.40(a). Specifically, during the inspection on 06/07/2017 our investigator observed the following:
a. Accumulation of food debris and residue on the stainless-steel blade of the horizontal dough mixer which contains numerous sections of weld with rough, uneven surfaces and excess pitting. You stated that employees will remove any visible food debris and rinse the equipment with water at the end of production but you do not use any soap, detergent, or sanitizer to clean your equipment.
b. Employees were observed using brushes to dry clean and remove food debris from the dough sheeter. The brushes bristles were soiled and frayed from repeated use and inadequate cleaning to remove the food debris. Furthermore, on 06/08/2017, the dough sheeter was observed to have food residue remaining even after cleaning was completed on 06/07/2017 following the production of egg-containing crackers.
c. Employees were observed placing long sheets of dough onto a wooden table and using a knife to manually slice the dough into smaller sections. This repeated scoring of dough with the knife has resulted over time in severe pitting and chips in the wooden table. Furthermore, on 06/08/2017, the wooden table was observed to have food residue remaining in these pits even after cleaning was completed on 06/07/2017 following the production of egg-containing crackers. This is a repeat observation from previous inspections.
d. The conveyor belts made out of a fabric material on the cracker cutting line, which is not an easily cleanable food contact surface, were found to be frayed and damaged. Furthermore, on 06/08/2017, the conveyor belts were observed to have food debris remaining on them even after cleaning was completed on 06/07/2017 following the production of egg-containing crackers. This is a repeat observation from previous inspections.
e. The rotating brush on the cracker cutting line was observed to have frayed and damaged bristles and an accumulation of apparent food debris. Furthermore, on 06/08/2017, this brush was observed to have food residue remaining on it even after cleaning was completed on 06/07/2017 following production of egg-containing crackers.
f. The rotary cutter on the cracker cutting line was observed to have a sponge-type material inserted into each mold on the die. This sponge-type material does not appear to be cleanable and you stated that these sponges are replaced as needed only when they begin to exhibit signs of deterioration. This is a repeat observation from previous inspections.
g. The metal sheet pans used to hold crackers during the baking process were observed to be covered in a layer of carbon buildup and food debris and several of the pans were observed to be cracked on the bottom. Furthermore, it was observed that employees allow the pans to cool after the baking process and then, without any rinsing or washing, return the pans to the beginning of the production line to receive the next batch of crackers. This is a repeat observation from previous inspections.
h. An engineered wood-type material was observed lining the inside bottoms of the rolling metal bins used to transport baked crackers prior to final packaging. This wood material, a food contact surface, was found to be chipped and peeling around the edges in each of the bins. This is a repeat observation from previous inspections.
i. Sheets of cardboard, which is not a cleanable material, were observed to be taped onto the shoot at the top of the bucket elevator to contain the crackers as they move from the buckets into the filling heads of the packing machine. Furthermore, on 06/08/2017, food debris and dust from the previous day’s production of egg-containing crackers was observed on the cardboard and inside the shoot at the top of the bucket elevator.
Your June 23, 2017 email response indicated you have removed the sheets of cardboard, which were observed to be taped onto the shoot at the top of the bucket elevator in order to contain the crackers as they move from the buckets into the filling heads of the packing machine (Item 3.i.). Your response is not adequate since you did not fully address the insanitary conditions we observed related to this issue. Furthermore, your responses are not adequate since you did not fully demonstrate you have corrected or plan to correct all of the issues observed.
4. Your firm failed to take effective measures to exclude pests from the processing areas, as required by 21 CFR 110.35(c). This is a repeat observation from previous inspections. Specifically, during the inspection our investigator observed the following:
a. Approximately 30 apparent rodent excreta pellets (REPs) were observed on the floor underneath and along the side of the employee hand wash sink located in the production area.
b. Too numerous to count apparent REPs were observed on a stack of unused pallets along the west facing wall of the loading dock area.
c. Too numerous to count apparent REPs were observed on a pallet located along the west facing wall of the loading dock area. This pallet was being used to store cardboard boxes used for finished product packing. Four apparent REPs were also found lying on top of the first box in the stack.
d. Approximately 10 apparent REPs were observed on a pallet containing old equipment and located beside the hopper used to store anise seeds.
e. Too numerous to count apparent REPs were observed underneath a pallet located on the left-hand side of the production facility beside the cracker cutting line. This pallet held cardboard boxes used for finished product packing.
f. The backdoor located next to the ovens consists of a traditional solid door plus a separate screened door. To allow for air flow during production, the solid door was observed to be opened while the screened door was left closed. However, the screen door has a gap of ~1 inch on the lower left-hand corner.
g. The loading dock door has gaps of ~1/2 inches between the floor and the bottom of the door.
h. Crackers and pieces of cracker were spilled on the floor underneath the conveyor line used to move the crackers from the oven area after baking and into the packing area. Approximately 6 apparent REPS were observed on the floor in this same area. Crackers were also left uncovered on the conveyor line.
During the inspection, you informed our investigator that you had hired a third party to provide pest control services on a (b)(4) and you stated that you would respond further in writing. Your June 22, 2017 email response included photos of repairs to the rear door of the facility. However, your response to date does not include further information such as a pest control service contract or monthly inspection records to demonstrate you have fully corrected all of the issues observed.
5. Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). This is a repeat observation from previous inspections. Specifically, during the inspection our investigator observed the following:
a. Flaking and peeling paint was observed in multiple areas of the ceiling in the production facility including above in-process dough and baked crackers that were uncovered.
b. Pipes and ductwork hanging from the ceiling in the production facility, including in the finished product packing area, were observed to be covered in dust.
c. A significant amount of unused and old equipment, pallets, and other miscellaneous items were observed to be stored throughout the production facility. These locations are potential harborage areas for rodents.
Your June 22, 2017 email response indicates that you are “researching the means of clearing out areas of the company that appear to have unused machinery, pallets” but you provide no further details. Your July 19, 2017 email response indicates you are preparing to purchase a cherry picker type of cage for your forklift so that you can address the issues with the ceiling and for general cleaning of the rafters and pipes. Your responses are not adequate since you did not provide a timeframe for the completion of corrections and you continue to manufacture ready-to-eat crackers under the observed conditions.
6. Your firm failed to provide employees with suitable outer garments that protect against contamination of food as required by 21 CFR 110.10(b)(1). Specifically, during the inspection our investigator observed employees were using their bare forearms to transfer in-process dough from the dough sheeter to a wooden table for slicing and then onto the cracker cutting line.
Your email responses do not address this observation.
7. Your firm failed to provide effective hand-cleaning and sanitizing preparations, as required by 21 CFR 110.37(e)(2). Specifically, during the inspection our investigator observed the hand wash sinks located in the men’s and women’s restrooms were lacking soap. Also, an apparent bar of soap not appropriate for cleaning hands was observed at the hand wash sink located in the production area. These are the only hand wash sinks available for the employees to use during production. This is a repeat observation from previous FDA inspections.
We acknowledge that prior to the close of our inspection you had placed a bar of soap at each of the hand wash sink locations. However, your email responses failed to provide details about how your firm intends to ensure sustained compliance regarding this observation. Despite your corrections during the inspection, this is a repeat observation observed during previous inspections and you have not demonstrated that your firm understands the significance of proper hand hygiene practices and can routinely sustain these practices to ensure the safety of the ready-to-eat foods that you manufacture.
8. Your firm failed to provide sanitary towel service or suitable hand drying devices as required by 21 CFR 110.37(e)(3). Specifically, on 06/07/17 and 06/08/17, the hand wash sinks located in the men’s and women’s restrooms, as well as the hand wash sink located in the production area, were all observed lacking a sanitary drying device, such as paper towels or automatic hand dryer. These are the only hand wash sinks available for the employees to use during production. This is a repeat observation from previous FDA inspections.
We acknowledge that prior to the close of our inspection you had placed paper towels at each of the hand wash sink locations. However, your email responses failed to provide details about how your firm intends to ensure sustained compliance regarding this observation. Furthermore, despite your corrections during the inspection, this same observation was noted during previous inspections, suggesting that your firm does not understand the significance of proper hand hygiene practices to ensure the safety of the ready-to-eat foods that you manufacture.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and 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 re-inspection-related costs. A re-inspection 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 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 U.S.C. 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at email@example.com
Program Division Director
Office of Human and Animal Food Operations East – Division 1
 Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.
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