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- Food & Beverages
Recipient NameMr. William H. Wolf
Recipient TitlePresident & Owner
- Peggy Lawton Kitchens, Inc.
255 Washington Street
East Walpole, MA 02032-1133
- Issuing Office:
- Division of Human and Animal Food Operations East I
158-15 Liberty Avenue
Jamaica, NY 11433
CMS # 586321
Dear Mr. Wolf:
The United States Food and Drug Administration (FDA) inspected your food manufacturing facility located at 255 Washington Street, East Walpole, MA 02032-1133 from May 28 through June 12, 2019, where you manufacture Ready-to-Eat (RTE) bakery products, including cookies and brownies. Our inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, [Title 21, Code of Federal Regulations, Part 117 (21 CFR 117)] (CGMP & PC rule).
Based on FDA’s inspectional findings, we have determined that the RTE food products manufactured in your facility are 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. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC 331(uu)]. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
We received your response, dated June 21, 2019, to the FDA Form 483, issued on June 12, 2019, which included a summary of corrective actions taken and planned by your firm. The adequacy of each of your firm’s promised corrective actions is discussed below and implementation of those actions will be assessed during our next inspection.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
The CGMP & PC rule creates new requirements for covered facilities to perform a hazard analysis and establish and implement risk-based preventive controls for human food. The CGMP & PC rule requires that you must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control [21 CFR § 117.130(a)]. The CGMP & PC rule further provides that you must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act [21 CFR § 117.135(a)(1)].
Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the
effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).
The CGMP & PC rule requires a food safety plan, which must include the following:
(1) The written hazard analysis, as required by § 117.130(a)(2);
(2) The written preventive controls, as required by § 117.135(b);
(3) The written supply-chain program, as required by subpart G;
(4) The written recall plan, as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);
(6) The written corrective action procedures, as required by § 117.150(a)(1); and
(7) The written verification procedures, as required by § 117.165(b).
During our inspection we determined that you did not prepare, or have prepared, and did not implement a food safety plan for the food manufactured in your ready-to-eat (RTE) cookie and brownie processing facility, as required by 21 CFR § 117.126, including preparing the written hazard analysis, as required by 21 CFR § 117.130. Based on your operation, when you perform your hazard analysis you should consider hazards including contamination of products with environmental pathogens, such as Listeria monocytogenes and Salmonella, and food allergens.
Your response outlines the corrective actions you have taken or plan to take, which includes modification of your recall plan. Your response does not include a hazard analysis or food safety plan. We do not have enough information to fully assess your promised corrective actions regarding your violations of the requirements in subpart C. We will verify the adequacy of your corrective actions during a future inspection.
Current Good Manufacturing Practice (Subpart B):
1. Your plant equipment and utensils used in manufacturing, processing, packing, or holding food are not designed and of such material and workmanship as to be adequately cleanable, and are not maintained adequately to protect against allergen cross-contact and contamination, as required by 21 CFR 117.40(a)(1). Specifically:
? On May 29, 2019, and June 5, 2019, empty bags of raw flour were observed placed over racks of ready-to-eat brownies and in direct contact with the pans of cooling brownies. The bags had apparent oil stains from previous usage of the bags to cover racks of cooling brownies. The flour bags were labeled with the following advisory language: “DO NOT EAT OR PLAY WITH RAW FLOUR, DOUGH OR BATTER***WASH HANDS, UTENSILS & SURFACES AFTER HANDLING” and “FOOD SAFETY ADVISORY: The raw flour contained in this bag is not ready-to-eat and must be thoroughly cooked before eating to prevent illness from bacteria. Do not eat or play with raw dough, wash hands, utensils, and surfaces after handling.”
? On May 29, 2019, multiple layers of electrical tape were observed wrapped around a cookie die. The cookie dough is pressed out of the die to make dough in the shape of cookies.
? On May 29, 2019, and May 30, 2019, ready-to-eat brownies were observed placed onto mats prior to being sliced. Areas of the mats appeared to be porous, and the ends of the mats were frayed.
? On May 29, 2019, a wire brush duct taped to a wooden pole was observed being used to remove cookie crumbs from the chain conveyor located before the first cooling tunnel. The duct tape was frayed, and there was as an accumulation of apparent food residue on the handle of the wire brush and duct tape and on the bristles of the wire brush.
? On May 29, 2019, Teflon-type paper and duct tape were observed wrapped around the sides of the cookie dough hopper with an accumulation of apparent dried cookie dough observed between the wax paper and the sides of the hopper.
Your response states that the raw flour bags are triple layered and only the inner layer is in direct contact with flour and that it is your opinion “that there is zero possibility of any raw flour coming into contact with ready to eat brownies.” You also state that all racks are constructed with a roof. Further, you assert that the wire brush taped to a wooden handle demonstrates you are “careful” in your processing facility.
The flour bags are permeable and can be split and/or damaged and opened while being stored. Some bags had apparent oil stains from previous usage of the bags to cover racks of cooling brownies, which may contribute to cross-contact. The response does not include supporting documentation to show that the RTE brownie products are protected from bags of raw flour. Further, the use of electrical tape is poor processing/sanitation practice. Over time, food residue accumulates on the tape. The use of duct tape reflects equipment that is in disrepair or not being used for its intended use. Your response does not specifically address the other violations described above.
2. You did not clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR 117.35(d). Specifically, on May 29, 2019, the gray totes used for holding brownie scraps were observed to have an accumulation of apparent food residue on the inside of the tote that comes into direct contact with the brownie scraps that are used to manufacture brownies.
Your response does not address this violation.
3. You did not clean non-food-contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 117.35(e). Specifically, on May 29, 2019, an employee was observed removing sheet pans of cooked brownies and placing them on a rack immediately beneath sheets pans of uncooked brownies. Additionally, your firm uses the same oven racks for holding sheet pans of uncooked brownies prior to placing the sheet pans in the oven and for holding pans of cooked brownies after they are baked. The brownie racks, which are not placed in the oven, are cleaned every (b)(4) to (b)(4) and were observed to be soiled with apparent uncooked brownie batter and cooked brownie particles.
Your response states that because the pan racks contact the underside of the pans for only about 2 inches on each end “there is almost no chance that any raw brownie batter can drip over the edge of an unbaked pan and fall onto ready to eat brownies below (unless a high velocity air flow blew it there or someone or something collided forcefully with the rack).”
Placing the finished product under raw product creates the possibility of cross contamination if the raw, uncooked product drips onto the finished product. Further, using the same oven racks for holding sheet pans of cooked and uncooked brownies creates the possibility of cross contamination if the sheet pans are not cleaned on a frequent basis. Your response does not provide a corrective action or supporting documentation that a correction/repair was made to address these violations.
4. You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically:
? You use a dishwasher to clean food contact equipment and utensils including brownie mats, brownie sheet pans, totes for holding brownie scraps, mixing bowls, and mixing bowl paddles. Typically, you load the dishwasher with water and detergent at the beginning of the day. This water/detergent mixture is recycled all day and is not discharged until the end of the day. Additionally, the dishwasher does not utilize a chemical sanitizing agent. The highest temperature achieved during a complete wash cycle according to the temperature monitoring probe on the dishwasher was observed to be 142 °F.
? On May 29, 2019, multiple layers of duct tape with frayed ends were observed wrapped around the handle of the knife used for scraping dough inside the cookie dough hopper.
Your response includes information regarding your (b)(4) and states, “The wash water ‘observed to be 142 degrees F’ has pan soap added throughout the day since according to the manufacturer the FRESH HOT WATER RINSE ‘reverts to the wash tank, removing grease and scum from the wash solution by providing a skimming action through the overflow funnel.’"
Your response does not provide any information or supporting documentation indicating that 142°F is an adequate temperature to clean and sanitize equipment. Further, the information for the (b)(4) provided in your response does not provide adequate model, time, temperature, and sanitizer information for FDA review. We note that the 2017 Food Code specifies that the temperature of the wash solution in mechanical warewashing equipment that uses hot water to sanitize may not be less than 165°F for a stationary rack, single temperature machine; 150°F for stationary rack, dual temperature machine; 160°F for single tank, conveyer, dual temperature machine; and 150°F for a multitank, conveyer, multitemperature machine. Additionally, your response did not address the multiple layers of duct tape with frayed ends that were observed wrapped around the handle of the knife used for scraping dough inside the cookie dough hopper.
5. You did not use cleaning compounds and sanitizing agents for cleaning and sanitizing that are safe and adequate under the conditions of use, as required by 21 CFR 117.35(b)(1). Specifically:
? The agent used for cleaning and sanitizing food contact surfaces consists (b)(4), Production employees were observed using this mixture of (b)(4) to wipe down food contact equipment including brownie mats, round blades for slicing brownies, brownie packing line conveyor belts, and the conveyor belts on the cookie line.
? On May 29, 2019, the equipment used to manufacture brownie batter was cleaned with water only; the cleaning did not include the use of detergent, physical scrubbing, and a sanitizer.
Your response states that you washed the mixing paddles, cookie die, and implements in the A-F hot high-pressure pot washer, used compressed air in the packaging room to clean off the cookie magazines and cookie chutes, and washed the packing table belt with warm soapy water. Your response does not include information demonstrating that cleaning and sanitizing agents used throughout your processing environment are adequate for use on food processing equipment and that you are properly cleaning and sanitizing equipment.
6. Your plumbing was not of adequate design and adequately installed and maintained to prevent backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food of food manufacturing, as required by 21 CFR 117.37(b)(5). Specifically, a hose at a two-bay sink was connected to a drum containing floor cleaner. The hose was equipped with a shut off valve where the hose connects to the drum. The hose lacked an appropriate backflow prevention device.
Your response asks FDA to provide additional information regarding the correct device for backflow prevention. It is your responsibility to ensure food and food manufacturing is protected from piping systems that discharge waste water or sewage within your food processing facility. You did not provide documentation that you have corrected this violation.
7. You did not provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature, as required by 21 CFR 117.37(e). Specifically, the hand washing sinks located in the cookie packing room were observed to not be operating from May 28, 2019 – May 30, 2019. Additionally, the sink located in the ingredient prep area and the sink located between the dishwasher and floor cleaner dispenser were not equipped with hand sanitizer.
Your response indicates that sinks are now equipped with hand cleaner and paper towel dispensers and that you repaired the sinks in the cookie packing room. Your response does not include supporting corrective action documentation of the repair.
8. Employees did not wear outer garments suitable to the operation in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food packaging materials, as required by 21 CFR 117.10(b)(1). Specifically, on May 29, 2019, an employee working in the brownie mixing area was observed to have heavily soiled pants at the beginning of the production day (approximately 5:35 AM) and the employee’s clothing became increasingly more soiled throughout the work day. The employee's soiled pants were observed coming into direct contact with the edge of the depositor hopper each time they leaned over the brownie depositor hopper as they scraped the contents of the brownie batter mixing bowl into the depositor hopper.
Your response indicates that each employee is instructed to read the firm’s “Employee Guide To Food Safety” and answer questions regarding the guide; however, the response does not include any supporting corrective action documentation that training is conducted with each employee and that training documents are maintained in the facility. The response also states that re-training needs to be conducted, but the response does not include the type of training that will be implemented or include a timeframe for completion of the training.
9. You did not take reasonable measures and precautions to ensure employees are washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and any other time when the hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically:
? On May 29, 2019, an employee working in the brownie mixing area was observed routinely submerging their bare hands and forearms, which were soiled with uncooked brownie batter, into a white bucket of water, wiping their wet hands on the front of their pants and sides of their shirt, filling baking sheets with brownie batter and moving racks of cooked brownies into the humidifier. The same employee was observed using a rag to clean shortening from the floor with their bare hands. The employee was observed folding the rag over onto itself such that their bare hands were in direct contact with the part of the rag that had contacted the floor. The employee then dipped their hands and arms into the bucket of water, wiped their hands and arms on the side of their pants, reached into a mixing bowl containing brownie batter and scraped down the inside of the bowl. A second employee working in the brownie mixing area was observed routinely submerging their soiled hands into a red bucket of water. After submerging their hands into the bucket, they returned to their mixing station where they continued to sift the flour to be used in brownie batter. Prior to beginning manufacturing operations, the red bucket was observed to be stored amongst several other red buckets and other floor cleaning supplies. The water in the buckets was not changed throughout the entire production day and appeared to be heavily soiled with organic matter.
? On May 30, 2019, the maintenance employee was observed adjusting the cookie dies on the cookie dough depositor. The employee did not wash their hands before conducting this activity, and they were observed wrapping their whole arm around the row of cookie dies as they adjusted this equipment. The employee was also observed using a pair of adjustable pliers that were previously stored on the floor to adjust this food contact equipment. The row of cookie dies was then pushed back into place and operations were resumed. Shortly thereafter, a production employee was observed adjusting the cookie dies on the cookie dough depositor. The employee did not wash their hands before conducting this activity, and they were observed wrapping their whole arm around the row of cookies. The row of cookie dies was then pushed back into place, and operations were resumed.
? On May 28, 2019 and May 30, 2019, employees packaging ready-to-eat cookies were observed to not wash or sanitize their hands (or sanitize their gloved hands) prior to handling the cookies, after touching boxes and using tools to fix equipment.
? On May 29, 2019 and May 30, 2019, employees packaging ready-to-eat brownies were observed to not wash and sanitize their hands prior to handling brownies with their bare hands after touching insanitary objects including dishwasher buttons with brown residue and conveyor belt switches that were observed to be encrusted with apparent brownie residue. The same employees were observed to not wash and sanitize their bare hands (or sanitize their gloved hands) after returning from break and continuing to work with the ready-to-eat brownies.
Your response does not specifically address these violations other than stating that perhaps the investigator did not see the employees wash their hands. Your response does not include, for example, documentation of employee training on proper hand washing practices.
10. You did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact and contamination of food, as required by 21 CFR 117.80(c)(2). Specifically, the last batch of cookies manufactured on May 28, 2019, consisted of Chocolate Chip Cookies (which contain walnuts), and the first batch of cookies manufactured on the same equipment on May 30, 2019 (the next day of manufacturing), were Oatmeal Cookies (which do not contain walnuts). The equipment was inspected at the end of the day on May 28, 2019, but on May 30, 2019, prior to manufacturing the Oatmeal Cookies, cookie and cookie residue were observed on the chain conveyors, turn tables, cookie magazines, and cookie chutes. You stated the last time the conveyors were cleaned was January 2019.
Your response does not specifically address the observation identified above. Your response states you washed the mixing paddles, cookie die, and implements in the (b)(4) pot washer and used compressed air in the packaging room to clean off the cookie magazines and cookie chutes. Your response does not address cookie residue on the chain conveyers or possible cross-contact with allergens, like walnuts. Further, your response does not address how you will avoid similar violations in the future.
11. You failed to maintain raw materials and other ingredients received and stored in bulk form in a manner that protects against allergen cross-contact and against contamination, as required by 21 CFR 117.80(b)(7). Specifically, on May 28, 2019, an exposed bulk size (b)(4) was observed stored on top of unopened cardboard boxes (b)(4).
Your response states that the (b)(4) was not in contact with the unopened cardboard boxes; however, FDA observed one, half dollar sized spot of (b)(4) at the top of the exposed cube that was in direct contact with an unopened cardboard box of (b)(4).
12. You did not adequately maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically:
? The flooring near the brownie mixing station and brownie oven was observed to have an accumulation of apparent food residue and grime after cleaning was conducted on May 29, 2019. Additionally, floor tiles were observed in disrepair with an accumulation of apparent food residue and grime in the production area.
? Water was observed pooling over the floor drain where brownie packing operations are conducted and where employees stand and walk when packaging brownies. Additionally, pooling water was observed in an area along the wall near the shortening dispenser in the brownie batter prep area. Pooling water can create a harborage area for pathogens to grow and contribute possible contamination of finished products.
? Paint was observed to be peeling and chipping along the wall behind the flour sifter where opened buckets of flour were held.
? The door frames to the humidifier tunnel contained apparent rust and flaking paint.
Additionally, the walls inside the humidifier tunnel where racks of brownies are stored against the wall contained flaking paint.
Your response does not address the flooring in disrepair throughout your facility, the pooling water, or the apparent rust and flaking paint on the door frames to the humidifier tunnel. Your response also does not address the sides of the racks that are exposed to the environment, specifically the rust and flaking paint on the door frames.
13. You did not have records documenting training in the principles of food hygiene and food safety for employees who manufacture, process, pack, or hold brownies, as required by 21 CFR 117.4.
Your response indicates that each employee is instructed to read the firm’s “Employee Guide to Food Safety” and answer questions regarding the guide. The response does not include any supporting corrective action documentation that training is conducted with each employee and that training documents are maintained in the facility. The response also states that re-training needs to be conducted, but your response does not indicate the type of training that will be implemented or include a timeframe for completion of the training.
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 reinspection fees, [21 USC 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 non-compliance 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: W. Martin Rennells, Compliance Officer, One Winner’s Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Mr. Rennells at 518-453-2314 x 1038 or email@example.com.
Program Division Director
Office of Human and Animal Food Operations -
East Division 1