"We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections."
The initial inspection found a number of issues, nothing overly serious. but mostly what could be considered sloppy procedures. This included multiple condensation issues, improper sanitation procedures with instances where too high a sanitizer concentration was used, potential cross contamination issues, inadequate handwashing water temperatures, and improperly marked sanitizing agents. Environmental sampling of 100 samples was negative for Listeria monocytogenes, but one sample was positive for a non-pathogenic species of Listeria.
Clearly some bad vibes going on between the agency and the plant. If issues were so bad, why did a follow-up inspection not occur, or why wasn't this letter issued in March? A lot to take away from this.
- Tighten up procedures now rather than having an agency inspector tell you. Inspections are rarely perfect, but the number of issues seen here show a lack of attention to detail.
- Ensure corrective actions to inspection reports are completed as soon as possible.Those corrective actions must be detailed / documented to cover each and every element addressed in the inspection and be able to demonstrate that the risk issues have been adequately addressed . Overkill in documentation support was needed here rather than glossing over.
Boston Globe
https://www.bostonglobe.com/business/2016/06/14/whoole-foods-kitchen-everett-hit-with-food-safety-violations/U2oSoRitbt1FeV9s3hFf4K/story.html
FDA inspectors find evidence of Listeria at Whole Foods kitchen
By Megan Woolhouse Globe Staff June 14, 2016
The Food and Drug Administration has warned Whole Foods Markets to resolve serious violations found at a regional food preparation facility in Everett after inspectors discovered condensation from ceiling pipes dripping on food, as well as evidence of the germ Listeria.
Last week, the federal agency sent a lengthy letter to Whole Foods citing an extensive list of food safety violations during multiple visits in February to the company’s kitchen in Everett, which makes ready-to-eat foods for 74 stores in Northeastern states.
The agency said Whole Foods’ initial response to the violations was unacceptable because the company did not offer sufficient documentation about how it would correct the problems at the 70,000-square-foot facility and ensure compliance with health and safety rules.
“FDA has serious concerns that our investigators found your firm operating under these conditions,” according to the June 8 warning letter, which was first reported by Bloomberg.
Whole Foods’ global vice president of operations, Ken Meyer, said in a statement issued Tuesday evening that he was “honestly surprised” by the warning and that the company has taken “thorough and tangible steps” to address problems. “We’ve been in close contact with the FDA, opened our doors to inspectors regularly since February, and worked with them to address every issue brought to our attention,” Meyer said.
FDA inspectors who visited the Everett plant, known as Whole Foods Market North Atlantic Kitchen, wrote that they saw condensation dripping onto surfaces where dishes such as pesto pasta and mushroom quesadillas were being prepared or stored, as well as uncovered barrels of egg salad “that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second.”
The FDA inspectors also found a type of Listeria that indicated the presence of a more severe form of the germ when they tested swabs of more than 100 surfaces throughout the facility. The letter said it found Listeria welshimeri, a form of the bacteria that the FDA said is an indicator of the probable presence of Listeria monocytogenes, a potentially deadly form of the bacteria. The Centers for Disease Control and Prevention said it is a particular threat to pregnant women and those with weakened immune systems.
In one instance, the inspectors found that a hand-washing station did not have hot water, yet was used by employees returning from a break before they began preparing food. Inspectors also said they saw an employee spray ammonium-based sanitizer on an open colander of salad greens and found sheet pans used for raw meats and ready-to-eat food products soaking in tanks with inadequate levels of sanitizer.
The letter further cited problems with workers using improperly diluted disinfectant in heavier than necessary amounts to clean vegetables.
Whole Foods has 15 business days to respond to the FDA’s letter.
The Everett facility warning is a blow for a company that is generally known for the pride it takes in high-quality products, which typically come with a high price tag. The Austin, Texas based chain is also widely credited with helping to bring about the organic food revolution.
One of the most worrisome findings, said Mel Kramer, president of EHA Consulting Group Inc., a Baltimore firm that advises restaurants and food manufacturers on food safety, was the inattention to how vegetables were washed. The use of too much disinfectant, he said, can lead to serious gastric problems such as diarrhea.
“This is pretty serious from a major company that the public generally looks to as a good actor,” said Kramer, who said he had reviewed the FDA warning letter at the request of the Globe. “An inspection is a picture, and the picture during those inspections was pretty poor.”
FDA spokeswoman Lauren Sucher said the agency could not disclose what prompted the Everett inspection. The FDA is tasked with monitoring food intended for interstate commerce under the Federal Food, Drug and Cosmetic Act.
Sucher said she could not say how often the agency and its regional offices inspect facilities because those decisions are made and adjusted during the year and depend on a variety of factors, such as a company’s prior history of compliance and risks associated with a specific commodity.
A Whole Foods distribution center near Denver was issued at least one similar warning letter by the FDA in March 2014, according to the agency’s website.
“Your tuna, sardines, anchovy, mackerel, bluefish, mahi-mahi, and wahoo are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the letter said.
The Everett warning also comes seven months after Whole Foods voluntarily recalled products prepared and packaged in the same Everett kitchen facility, including curry chicken salad and classic deli pasta salad, after a routine inspection found possible Listeria contamination of the life-threatening sort, according to a list of product recalls posted on the FDA’s website.
Food safety problems have also plagued other Boston supermarkets. In April, the city of Boston shuttered a Roxbury Stop & Shop when workers failed to address unsanitary conditions in the store that included a mouse infestation. A subsequent Globe review of Boston food safety inspection data found that markets throughout the city had hundreds of violations, big and small, including 127 at the Whole Foods on Cambridge Street near Beacon Hill.
Megan Woolhouse can be reached at megan.woolhouse@globe.com. Follow her on Twitter @megwoolhouse.
FDA Warning Letter Notice
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506089.htm
Whole Foods Market North Atlantic Kitchen 6/8/16
WARNING LETTER
CMS # 492729
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
June 8, 2016
John Mackey, Co-Chief Executive Officer
Walter Robb, Co-Chief Executive Officer
Whole Foods Markets Inc.
550 Bowie Street
Austin, TX 78703
Dear Mr. Mackey & Mr. Robb:
The U.S. Food and Drug Administration (FDA) inspected your multiple food manufacturing facility, Whole Foods Market North Atlantic Kitchen, 9 Commercial St, Suite 300, Everett, MA 02149-5506, on February 10, 11, 16, 18, & 26, 2016. The inspection found serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] in that 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 its implementing regulations on FDA’s home page at www.fda.gov.
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Mr. Brian Corbley, Facility Team Leader at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1. Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). Specifically, we observed:
3. Your firm failed to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned as required by21 CFR 110.35(d)(1). Specifically,
6. Your firm failed to properly identify toxic sanitizing agents in a manner that protects against contamination of food as required by 21 CFR 110.35(b)(2). Specifically, we observed an unmarked drum of an unidentified chemical that was connected to the vegetable preparation sink in the Veg Prep Room. It was verbally identified as peracetic acid to be used to soak vegetables.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure.
Further, 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.
We acknowledge receipt of your March 17, 2016 written response to the FDA Form-483 Inspectional Observations, issued to your firm on February 26, 2016. This response states that your firm takes these observations seriously and that your senior leadership is committed to take all the necessary measures to correct all the deficiencies. Despite this, FDA has serious concerns that our investigators found your firm operating under these conditions. Further, your response includes retraining of employees as a corrective action for most of the observed violations but you failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance. We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at scott.loughan@fda.hhs.gov.
Sincerely,
/S/
Joseph Matrisciano Jr.
District Director
New England District
cc:
Mr. Ken Meyer
Executive Vice President of Operations
Whole Foods Market, Inc.
550 Bowie Street
Austin, TX 78703
Roberta Lang, President
Whole Foods Market Group, Inc.
550 Bowie Street
Austin, TX 78703
Ms. Laura Derba
North Atlantic Regional President
Whole Foods Market Group, Inc.
125 Cambridge Park Drive
Cambridge, MA 02140
Mr. Brian Corbley,
Facility Team Leader, Whole Foods Market North Atlantic Kitchen
Whole Foods Market Group, Inc.
9 Commercial St, Suite 300
Everett, MA 02149-5506
Whole Foods Market North Atlantic Kitchen 6/8/16
WARNING LETTER
CMS # 492729
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
June 8, 2016
John Mackey, Co-Chief Executive Officer
Walter Robb, Co-Chief Executive Officer
Whole Foods Markets Inc.
550 Bowie Street
Austin, TX 78703
Dear Mr. Mackey & Mr. Robb:
The U.S. Food and Drug Administration (FDA) inspected your multiple food manufacturing facility, Whole Foods Market North Atlantic Kitchen, 9 Commercial St, Suite 300, Everett, MA 02149-5506, on February 10, 11, 16, 18, & 26, 2016. The inspection found serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)] in that 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 its implementing regulations on FDA’s home page at www.fda.gov.
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Mr. Brian Corbley, Facility Team Leader at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1. Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). Specifically, we observed:
- On February 10, 2016, you were mixing ready to eat pesto pasta directly under an area in the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 16, 2016, you were storing an uncovered rack of ready to eat mushroom quesadilla in the same area of the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
- On February 10, 2016, your employee transported uncovered ready to eat vegetables through a doorway, from the Veg Prep Room into the Prepared Veg Cooler. A significant amount of condensate had formed above the doorway and was dripping onto the surface below.
- On February 10, 2016, your employee was cutting chives and beets on a work surface directly underneath a leaking condensate drainage pipe in the Veg Prep Room.
- On February 16, 2016, you were holding uncovered ready to eat egg salad in large white barrels that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second from the condenser fan bolts in the K8/K9 Room.
- On February 16, 2016, your employee transported uncovered ready to eat couscous through an area in the K8/K9 Room where condensate was dripping from an area around the condenser fan bolts at a rate of approximately once per second.
- On February 10, 16, & 18, 2016, you were holding ready to eat vegetables, utensils such as cutting boards, mandolins, stainless colanders and yellow plastic totes in close proximity to hand a washing station in the Veg Prep Room. The hand washing station does not have splash guards and is foot operated releasing water from the faucets with significant pressure causing water to splash outside the sink while employees were observed washing soiled hands. Water splashed onto covered and uncovered ready to eat vegetables, utensils and food containers.
- On February 16, 2016, your employee measured the strength of peracetic acid from the faucet in the Veg Prep Room with an (b)(4) Peracetic Acid test strip that indicated its strength over 160 ppm (maximum level on the test strip). This concentration exceeds the maximum level recommended by the (b)(4) product information sheet and the maximum level allowed under 21 CFR Part 173.315(a) (5) for use of peracetic acid for surface treatment and soaking and rinsing of vegetables.
- On February 16, 2016, your employee was performing multiple tasks in the Pre-Pack Room including filling and weighing ready to eat egg salad in retail packs. The employee was observed cleaning and directly contacting work surfaces and then packaging and handling exposed product without hand washing or changing gloves in between tasks.
- On February 16, 2016, your employee in the Bulk-Pack Room was observed assembling bulk cartons while also packaging exposed ready to eat quinoa cakes without hand washing or changing gloves in between tasks.
- On February 16, 2016, your employee in the Pre-Pack Room was spraying (b)(4) quaternary ammonium based sanitizer to clean work surfaces while another employee in close proximity was packaging exposed ready to eat mesculin salad. This resulted in the sanitizer being sprayed onto an open colander of salad leafy greens.
- On February 16, 2016, your employee’s unprotected upper sleeves were frequently touching ready to eat leafy salad greens as leafy salad greens were packaged into retail packs in the Pre-Pack Room.
3. Your firm failed to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned as required by21 CFR 110.35(d)(1). Specifically,
- On February 16, 2016, you filled the dip tank for soaking sheet pans (used for raw meats and ready to eat in process and finished products) with a quaternary ammonium based sanitizing agent. You measured the sanitizer strength using a color based test strip which indicated the sanitizer strength at 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
- On February 16, 2016, you measured the sanitizer strength on the spray nozzle located in the dish washing room that is used for filling the dip tank and for sanitizing larger portable equipment such as the rotating blades of (b)(4) machine and Ribbon Blender parts. The color based test strip indicated the sanitizer strength to be 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
- On February 16, 2016, you did not clean and sanitize the semi-permanent divider curtain in the K8/K9 Room after using a high pressure spray hose to clean and sanitize the ribbon blender and the walls and floors surrounding the ribbon blender.
- On February 10, 2016, you were storing various utensils and equipment parts inside containers and on rolling carts that had pooling water in or on them.
- You failed to keep soiled dishes separate from ready to eat products and you are using portable divider curtains and semi-permanent divider curtains to segregate areas between the dishwashing room entrance/exit doors and the Assembly Room where ready to eat products are assembled. Soiled and insanitary equipment from various preparation processes including holding of raw chicken and turkey were observed touching both sides of the portable divider curtains.
- On February 10 & 16, 2016, your employees in the K8/K9 Room used high pressure hoses to clean the ribbon blender and the semi-permanent divider curtains, causing water and aerosolized spray from the cleaning activity to go beyond the portable divider curtains and the semi-permanent divider curtains into areas where ready to eat food such as couscous and salad dressings were being prepared. The portable and semi- permanent divider curtains did not provide adequate protection of ready to eat food when high pressure hoses are used to clean and sanitize clean-in-place equipment and the portable and semi-permanent divider curtains.
- On February 10 & 16, 2016, soiled/unclean equipment , utensils and food containers had accumulated beyond the entrance of the dish washing room and portable divider curtains separating the dish washing room and the Assembly Area. This resulted in soiled/unclean equipment, utensils and food containers to be held for an indefinite period of time in close proximity to ready to eat manufacturing activities such as making of enchiladas, mixing of pesto pasta and quesadillas.
6. Your firm failed to properly identify toxic sanitizing agents in a manner that protects against contamination of food as required by 21 CFR 110.35(b)(2). Specifically, we observed an unmarked drum of an unidentified chemical that was connected to the vegetable preparation sink in the Veg Prep Room. It was verbally identified as peracetic acid to be used to soak vegetables.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure.
Further, 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.
We acknowledge receipt of your March 17, 2016 written response to the FDA Form-483 Inspectional Observations, issued to your firm on February 26, 2016. This response states that your firm takes these observations seriously and that your senior leadership is committed to take all the necessary measures to correct all the deficiencies. Despite this, FDA has serious concerns that our investigators found your firm operating under these conditions. Further, your response includes retraining of employees as a corrective action for most of the observed violations but you failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance. We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at scott.loughan@fda.hhs.gov.
Sincerely,
/S/
Joseph Matrisciano Jr.
District Director
New England District
cc:
Mr. Ken Meyer
Executive Vice President of Operations
Whole Foods Market, Inc.
550 Bowie Street
Austin, TX 78703
Roberta Lang, President
Whole Foods Market Group, Inc.
550 Bowie Street
Austin, TX 78703
Ms. Laura Derba
North Atlantic Regional President
Whole Foods Market Group, Inc.
125 Cambridge Park Drive
Cambridge, MA 02140
Mr. Brian Corbley,
Facility Team Leader, Whole Foods Market North Atlantic Kitchen
Whole Foods Market Group, Inc.
9 Commercial St, Suite 300
Everett, MA 02149-5506
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