A battle has begun between the corrugated container provides and the reusable plastic container (RPC) providers with regard to safety for handling produce. The corrugated container people cite two studies (that they paid for) that show contains can carry bacteria, while the RPC cite a history of use where there has been no documented cases of food safety issues related to these reusable plastic containers.
I guess my approach is more simplistic. If food surfaces are contaminated, they can be the source of contamination to the food the carry. That contamination can be pathogens or even spoilage organisms depending upon the application. So if you are willing to properly clean those containers, then that is great, but you better be able to validate that cleaning process. If not, there is the possibility of issues (depending on the application of use). Or you can consider using one-time-use corrugated containers that eliminate the risk.
Having worked in the industry for many years, I have seen reusable plastic containers that are down right disgusting. And I think the RPC industry is doing itself a disservice by not stating that these containers need to be properly cleaned and sanitized, especially in applications where that contamination can be harmful (for example, in refrigerated RTE applications where Listeria biofilm formation can lead to contamination).
In a world where sustainability is becoming a necessity, reusable containers will become an important part for reducing waste. But we cannot give those containers a pass because they are considered 'more sustainable'. For operations that wish to go in this direction, part of that investment must be the means for cleaning and sanitizing.
Even done to the consumer level where people have used reusable plastic containers for storing food. One company is selling reusable zip lock bags (bottom). That is great, as long as the consumers can adequately clean them.
The Packer
http://www.thepacker.com/fruit-vegetable-news/RPC-corrugated-groups-spar-over-food-safety-283218931.html?llsms=1051551&c=y
RPC, corrugated groups spar over food safety
11/19/2014 11:56:00 AM
Tom Karst
Two recent studies of bacteria on reusable plastic containers — both sponsored by corrugated carton groups — question the cleaning process used on RPCs before they enter the supply chain again. RPC supplier IFCO and the Reusable Packaging Association has countered that no foodborne illness outbreak has been traced to RPCS. Keith Warriner, professor of food safety at the University of Guelph in Ontario, Canada, said the study of RPCs — commissioned by the Canadian Corrugated and Containerboard Association — was an extension of one he performed in 2013. The first study tested 50 RPCs, while the 2014 study involved 160 RPCs. In the 2014 study, RPC samples from five Canadian packing facilities were pulled from different lots of trays that had been delivered on pallets wrapped with plastic film. Corrugated cartons from those facilities were not tested for comparison, Warriner said.
Thursday, November 20, 2014
Taco Seasoning Product Recalled for Peanut Allergen Due to Supplier Error
This is a great example where a supplier's poor allergen control program can lead to a recall by the company purchasing that used that contaminated ingredient in their products. In this case, a Mexican food processor purchased spice that was contaminated by peanut allergens that originated in the supplier's operation.
When purchasing ingredients, companies must rely on their supplier for controlling allergens, especially when that supplier handles a wide range of allergen containing ingredients. Spice and flavoring companies are two types of ingredient suppliers that often fit this description, but this can also includes most companies that have multiple ingredients (breading, processed meat products, etc), Purchasers need to know the types of allergens their suppliers are handling and the ability to control those allergens within their operation. In this particular case, peanut is a type of allergen where even a little amount can be very harmful to a person how is allergic.
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm423216.htm
B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product
Contact
Consumer: 877-929-2576 www.ortega.com
Media: Ernest DelBuono 202-973-1318
FOR IMMEDIATE RELEASE – November 14, 2014 – B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products. There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.
This recall affects the following products: See List
The recalled products were distributed in retail stores and foodservice outlets nationwide.
This recall does not apply to any other sizes or varieties of Ortega Seasoning Mix or to any Ortega Seasoning Mixes in canisters, all of which are correctly labeled. For example, this recall does not include Ortega Fajita Seasoning Mix, Ortega Fish Taco Seasoning Mix, Ortega Chili Seasoning Mix, Ortega Chipotle Seasoning Mix or Ortega Burrito Seasoning Mix, all of which are correctly labeled. This recall also does not include any Las Palmas Enchilada Sauce, which is correctly labeled.
“The safety of our consumers is our number one priority. We are committed to providing safe, quality products while observing the highest ethical standards in the conduct of our business,” said William Wright, Executive Vice President of Quality Assurance and R&D at B&G Foods. “The core values that we’ve embodied since the company was founded in the 1800s — honesty, integrity and accountability — guide our actions as we take the appropriate measures to address this issue.”
This recall was initiated in consultation with the FDA after it was discovered that ingredients from a single supplier used in the affected products were contaminated with peanut and almond allergens. B&G Foods has since terminated its relationship with this supplier and is receiving these ingredients from other sources in anticipation of resuming production shortly.
Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company’s recall hotline at 877-929-2576 from 8:00 a.m. ET to 8:00 p.m. ET, or visit www.ortega.com for additional information.
About B&G Foods
B&G Foods, Inc. (NYSE: BGS) and its subsidiaries manufacture, sell and distribute a diversified portfolio of high-quality, branded shelf-stable foods across the United States, Canada and Puerto Rico. Based in Parsippany, New Jersey, B&G Foods’ products are marketed under many recognized brands, including Ac’cent, B&G, B&M, Baker’s Joy, Bear Creek Country Kitchens, Brer Rabbit, Canoleo, Cary’s, Cream of Rice, Cream of Wheat, Devonsheer, Don Pepino, Emeril’s, Grandma’s Molasses, JJ Flats, Joan of Arc, Las Palmas, MacDonald’s, Maple Grove Farms, Molly McButter, Mrs. Dash, New York Flatbreads, New York Style, Old London, Original Tings, Ortega, Pirate’s Booty, Polaner, Red Devil, Regina, Rickland Orchards, Sa‑són, Sclafani, Smart Puffs, Spring Tree, Sugar Twin, Trappey’s, TrueNorth, Underwood, Vermont Maid and Wright’s. B&G Foods also sells and distributes two branded household products, Static Guard and Kleen Guard.
When purchasing ingredients, companies must rely on their supplier for controlling allergens, especially when that supplier handles a wide range of allergen containing ingredients. Spice and flavoring companies are two types of ingredient suppliers that often fit this description, but this can also includes most companies that have multiple ingredients (breading, processed meat products, etc), Purchasers need to know the types of allergens their suppliers are handling and the ability to control those allergens within their operation. In this particular case, peanut is a type of allergen where even a little amount can be very harmful to a person how is allergic.
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm423216.htm
B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product
Contact
Consumer: 877-929-2576 www.ortega.com
Media: Ernest DelBuono 202-973-1318
FOR IMMEDIATE RELEASE – November 14, 2014 – B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products. There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.
This recall affects the following products: See List
The recalled products were distributed in retail stores and foodservice outlets nationwide.
This recall does not apply to any other sizes or varieties of Ortega Seasoning Mix or to any Ortega Seasoning Mixes in canisters, all of which are correctly labeled. For example, this recall does not include Ortega Fajita Seasoning Mix, Ortega Fish Taco Seasoning Mix, Ortega Chili Seasoning Mix, Ortega Chipotle Seasoning Mix or Ortega Burrito Seasoning Mix, all of which are correctly labeled. This recall also does not include any Las Palmas Enchilada Sauce, which is correctly labeled.
“The safety of our consumers is our number one priority. We are committed to providing safe, quality products while observing the highest ethical standards in the conduct of our business,” said William Wright, Executive Vice President of Quality Assurance and R&D at B&G Foods. “The core values that we’ve embodied since the company was founded in the 1800s — honesty, integrity and accountability — guide our actions as we take the appropriate measures to address this issue.”
This recall was initiated in consultation with the FDA after it was discovered that ingredients from a single supplier used in the affected products were contaminated with peanut and almond allergens. B&G Foods has since terminated its relationship with this supplier and is receiving these ingredients from other sources in anticipation of resuming production shortly.
Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company’s recall hotline at 877-929-2576 from 8:00 a.m. ET to 8:00 p.m. ET, or visit www.ortega.com for additional information.
About B&G Foods
B&G Foods, Inc. (NYSE: BGS) and its subsidiaries manufacture, sell and distribute a diversified portfolio of high-quality, branded shelf-stable foods across the United States, Canada and Puerto Rico. Based in Parsippany, New Jersey, B&G Foods’ products are marketed under many recognized brands, including Ac’cent, B&G, B&M, Baker’s Joy, Bear Creek Country Kitchens, Brer Rabbit, Canoleo, Cary’s, Cream of Rice, Cream of Wheat, Devonsheer, Don Pepino, Emeril’s, Grandma’s Molasses, JJ Flats, Joan of Arc, Las Palmas, MacDonald’s, Maple Grove Farms, Molly McButter, Mrs. Dash, New York Flatbreads, New York Style, Old London, Original Tings, Ortega, Pirate’s Booty, Polaner, Red Devil, Regina, Rickland Orchards, Sa‑són, Sclafani, Smart Puffs, Spring Tree, Sugar Twin, Trappey’s, TrueNorth, Underwood, Vermont Maid and Wright’s. B&G Foods also sells and distributes two branded household products, Static Guard and Kleen Guard.
Bratwurst Recalled for Allergen Mislabeling Due to Soy Lecithin
Earlier this week, USDA posted a recall notice for a Pennsylvania company that was using soy lecithin as a processing aid and did not have the allergen claim on the label. Now another Pennsylvania company has issued a recall for doing the same thing - using a releasing agent containing soy lecithin and not claiming it on the label.
When the dog is on a scent, he's going to keep huntin'. That is, now that USDA sees that there is an issue here that is not being properly addressed, those inspectors are going to be looking for it. My bet is that this is not the last recall for soy lecithin mislabeling.
USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-080-2014-release
Pennsylvania Firm Recalls Pork Products Due To Misbranding and Undeclared Allergens
Class II Recall 080-2014
Health Risk: Low Nov 19, 2014
Congressional and Public Affairs Felicia Thompson (202) 720-9113
WASHINGTON, Nov. 19, 2014 – K. Heeps, Inc., an Allentown, Pa., establishment is recalling approximately 2,902 pounds of Bratwurst and Bangers sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy lecithin; a releasing agent used on contact surfaces during production and is a known allergen.
When the dog is on a scent, he's going to keep huntin'. That is, now that USDA sees that there is an issue here that is not being properly addressed, those inspectors are going to be looking for it. My bet is that this is not the last recall for soy lecithin mislabeling.
USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-080-2014-release
Pennsylvania Firm Recalls Pork Products Due To Misbranding and Undeclared Allergens
Class II Recall 080-2014
Health Risk: Low Nov 19, 2014
Congressional and Public Affairs Felicia Thompson (202) 720-9113
WASHINGTON, Nov. 19, 2014 – K. Heeps, Inc., an Allentown, Pa., establishment is recalling approximately 2,902 pounds of Bratwurst and Bangers sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy lecithin; a releasing agent used on contact surfaces during production and is a known allergen.
Wednesday, November 19, 2014
Fifteen Postal Workers Ill from Potluck Leftovers
Potlucks are one thing, but leftovers from potlucks..... In this case, 15 postal workers become ill after consuming leftovers from a potluck dinner held for 200 to honor veterans.
What was the issue? While the news reports are light on information, we can make a pretty good guess. First, no one got sick from the initial offering, but rather it was the nightshift workers who became ill after consuming the leftovers. The symptoms of vomiting and nausea were noted and it occurred about 6 hours or so after their shift began. The short duration from consumption to onset of the illness in conjunction with the symptoms of vomiting and nausea would indicate a Staphylococcus aureus intoxication. If that is the case, we could guess that some of the leftovers were not properly refrigerated.
What was the issue? While the news reports are light on information, we can make a pretty good guess. First, no one got sick from the initial offering, but rather it was the nightshift workers who became ill after consuming the leftovers. The symptoms of vomiting and nausea were noted and it occurred about 6 hours or so after their shift began. The short duration from consumption to onset of the illness in conjunction with the symptoms of vomiting and nausea would indicate a Staphylococcus aureus intoxication. If that is the case, we could guess that some of the leftovers were not properly refrigerated.
Pretzel Dogs Recalled Due to Use of Soy Lecithin Not Listed on Label
A Pennsylvania firm is recalling pretzel dogs due to the fact that soy lecithin was not included on the label. In this case, the soy lecithin was used as a processing aid, more specifically a release agent (like Pam). But the need to claim soy lecithin, when used as a processing aid, was not always clear cut.
From the Food Allergy Research and Resource Center (FARRP website link below),
But in the past, it was not as clear with regard to soy lecithin. More from FARRP:
It is important that food operations review their use of processing aids. If allergens are present such as soy lecithin, it needs to be included on the label.
From the Food Allergy Research and Resource Center (FARRP website link below),
The Food Allergen Labeling and Consumer Protection Act in the U.S. requires the labeling of soy lecithin when used in any capacity, including use as a processing aid.
But in the past, it was not as clear with regard to soy lecithin. More from FARRP:
Additionally, on February 25, 2013, the FDA withdrew its May 2, 2006 guidance entitled "Guidance on the Labeling of Certain Uses for Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act" which originally indicated a willingness by FDA to use "regulatory discretion" in dealing with the labeling of soy lecithin in circumstances where soy lecithin is used as a stick-release or pan-release agent, a common processing aid use in the food industry. The FDA now requires source labeling of soy lecithin when used as a release agent applied directly to the food contact surfaces or as a direct ingredient in the product formulation, with the exception of the specificAnother thing that FARRP points out is that the level of allergen present on the product when used as a processing aid may be well below the limit that will cause anyone to have a reaction. However, there may be that one case.
It is important that food operations review their use of processing aids. If allergens are present such as soy lecithin, it needs to be included on the label.
USDA News Release
Pennsylvania Firm Expands Recalls Pretzel Dog Products Due To Misbranding and Undeclared Allergens
Class I Recall 079-2014-EXP Health Risk: High Nov 18, 2014
Monday, November 17, 2014
Norovirus Outbreak on Cruise Ship Affects Over 170
An outbreak of Norovirus occurred on a cruise ship a few days after leaving port where over 170 people, including both passengers and crew members, became ill. The trip was scheduled for a one month long trip. Because Norovirus can spread so quickly, the boat was docked to allow the sick passenger's to disembark.
Concession Stands at KC Professional Sports Stadiums Cited for Food Safety Issues
Health inspectors discovered a number of food safety issues when conducting inspections of the two professional stadiums in Kansas City.
Concession operations that are used infrequently (at least not every day) need to take into account that they have a flurry of activity for 4 to 6 hours and then are not used for days or weeks afterwards. Items that are not cleaned will sit around for days, attracting pests such as cockroaches or mice. Another issue they face is that the people who work there may be temporary workers or even volunteers. Getting these people up to speed on food safety fundamentals in an hour or so can be a challenge, especially if there is high turnover from event to event and/or there is lack of long term worries by the employee.
These issues can increase the risk that something will not be done correctly including improper clean-up after the event is over, or mishandling food during the event by the less-than-knowledgeable workers. In the end, this can make the chance of food contamination higher, resulting in consumers contracting foodborne illness or a poor health inspection. These will lead to bad publicity for the organization, even if that organization had no involvement in making the food. In this case, the KC Chiefs or Royals. Further, in light of the high food prices paid at these events, consumer backlash can be great, and revenue loss even greater (see attached story below).
It is important for any operations that operate temporary food events to have tight controls over handling and clean-up. Self-inspections during and after the event by facility managers is important in ensuring compliance.
Kansas City Star
http://www.kansascity.com/news/business/article3941505.html
Health inspections find problems at Arrowhead Stadium and Kauffman Stadium
By MARK DAVIS The Kansas City Star
11/14/2014 6:29 PM 11/14/2014 9:23 PM
Kansas City health officials were concerned and disappointed by conditions they found at Arrowhead and Kauffman stadiums during recent food safety inspections.
Reports itemized 37 critical violations of food safety among 26 concession stands and the main kitchens inside the two parks on Nov. 3, the Monday after the Kansas City Chiefs defeated the New York Jets.
Concession operations that are used infrequently (at least not every day) need to take into account that they have a flurry of activity for 4 to 6 hours and then are not used for days or weeks afterwards. Items that are not cleaned will sit around for days, attracting pests such as cockroaches or mice. Another issue they face is that the people who work there may be temporary workers or even volunteers. Getting these people up to speed on food safety fundamentals in an hour or so can be a challenge, especially if there is high turnover from event to event and/or there is lack of long term worries by the employee.
These issues can increase the risk that something will not be done correctly including improper clean-up after the event is over, or mishandling food during the event by the less-than-knowledgeable workers. In the end, this can make the chance of food contamination higher, resulting in consumers contracting foodborne illness or a poor health inspection. These will lead to bad publicity for the organization, even if that organization had no involvement in making the food. In this case, the KC Chiefs or Royals. Further, in light of the high food prices paid at these events, consumer backlash can be great, and revenue loss even greater (see attached story below).
It is important for any operations that operate temporary food events to have tight controls over handling and clean-up. Self-inspections during and after the event by facility managers is important in ensuring compliance.
Kansas City Star
http://www.kansascity.com/news/business/article3941505.html
Health inspections find problems at Arrowhead Stadium and Kauffman Stadium
By MARK DAVIS The Kansas City Star
11/14/2014 6:29 PM 11/14/2014 9:23 PM
Kansas City health officials were concerned and disappointed by conditions they found at Arrowhead and Kauffman stadiums during recent food safety inspections.
Reports itemized 37 critical violations of food safety among 26 concession stands and the main kitchens inside the two parks on Nov. 3, the Monday after the Kansas City Chiefs defeated the New York Jets.
Friday, November 14, 2014
Man Requires Surgery After Consuming Pizza Contaminated With Wire Bristles
As reported on the Marler Blog, a man required surgery to remove two small pieces of wire that had become lodged in his intestines, one of them piercing the intestinal wall. The wire pieces came from a pizza he ate, originating from a wire brush that was used by the pizza shop.
As sited in the article, investigators inspected the shop and “Observed a wire brush with food debris between the wires. Wires on the brush were bent and pointing in different directions and did not maintain its original design. Employee stated they had another brush that was used to clean the oven but was discarded last week. Person in charge stated the outside of the oven is cleaned every night and the inside of the oven is cleaned once a month using the brush.”
This is not the first issue involving wire bristles from an overused wire brush. In another recent case, a man required surgery when a wire bristle was inadvertently consumed via a steak from the grill. (http://pennstatefoodsafety.blogspot.com/2012/05/metal-bristle-from-grill-brush-example.html).
Operations must consider the risks of using metal bristled brushes, and where possible, look for alternatives. If they are used, care must be taken to ensure that bristles are not shed onto the equipment surface and that those brushes are replaced regularly, certainly if it is expected that the wires can become dislodged.
Wire Brush and Pizza – Not a Good Mix Posted
By Bill Marler on November 13, 2014
http://www.marlerblog.com/legal-cases/wire-brushes-and-pizza-not-a-good-mix/#.VGYOj010yUl
On the evening of Friday, September 19, 2014 Diane Norman bought pizzas at Domino’s Pizza located at 2800 Milton Way in Milton, Washington. She took the pizzas home for her family to consume. Michael Norman chose two slices of Canadian bacon and pineapple pizza and took a bite of one slice. He swallowed and immediately felt something sharp in his throat. He started to choke and dashed to the sink to drink water to help clear his throat. At this point he felt a sharp tearing at his throat and drank a glass of cranberry juice. His throat felt scratched and to relieve his pain he ate a slice of bread. Although this action eliminated the feeling that food was lodged in his throat, Michael felt a dull pain in his stomach. Since he was no longer felt hungry, he did not eat any more pizza. Diane Norman froze the remaining leftover pizza. Sometime later she examined the frozen pizza slices and found a wire in a piece of the pizza she had saved.
As sited in the article, investigators inspected the shop and “Observed a wire brush with food debris between the wires. Wires on the brush were bent and pointing in different directions and did not maintain its original design. Employee stated they had another brush that was used to clean the oven but was discarded last week. Person in charge stated the outside of the oven is cleaned every night and the inside of the oven is cleaned once a month using the brush.”
This is not the first issue involving wire bristles from an overused wire brush. In another recent case, a man required surgery when a wire bristle was inadvertently consumed via a steak from the grill. (http://pennstatefoodsafety.blogspot.com/2012/05/metal-bristle-from-grill-brush-example.html).
Operations must consider the risks of using metal bristled brushes, and where possible, look for alternatives. If they are used, care must be taken to ensure that bristles are not shed onto the equipment surface and that those brushes are replaced regularly, certainly if it is expected that the wires can become dislodged.
Wire Brush and Pizza – Not a Good Mix Posted
By Bill Marler on November 13, 2014
http://www.marlerblog.com/legal-cases/wire-brushes-and-pizza-not-a-good-mix/#.VGYOj010yUl
On the evening of Friday, September 19, 2014 Diane Norman bought pizzas at Domino’s Pizza located at 2800 Milton Way in Milton, Washington. She took the pizzas home for her family to consume. Michael Norman chose two slices of Canadian bacon and pineapple pizza and took a bite of one slice. He swallowed and immediately felt something sharp in his throat. He started to choke and dashed to the sink to drink water to help clear his throat. At this point he felt a sharp tearing at his throat and drank a glass of cranberry juice. His throat felt scratched and to relieve his pain he ate a slice of bread. Although this action eliminated the feeling that food was lodged in his throat, Michael felt a dull pain in his stomach. Since he was no longer felt hungry, he did not eat any more pizza. Diane Norman froze the remaining leftover pizza. Sometime later she examined the frozen pizza slices and found a wire in a piece of the pizza she had saved.
Wednesday, November 12, 2014
Applying the Drug Guidance "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection" to Food Operations
FDA recently issued a guidance for drug related companies titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection". Some have suggested that this type of guidance may be extended to food processing facilities that fall under FDA jurisdiction.
It is stated in this guidance:
The categories defined in the guidance include 1) Delay of inspection (pushing back an inspection, holding up during an inspection, delaying of getting records), 2) Denial of inspection, 3) Limiting an inspection (limiting access, limiting photography, limiting access to records or the copying of those records, and limiting or preventing the collection of samples, and 4) Refusal to permit entry.
It may be worth the time to gain an understanding of this guidance and what constitutes the definitions in preventing access. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf
It is stated in this guidance:
It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry or inspection or refuse to permit access to or copying of certain specified records.10 New section 501(j) of the FD&C Act, as added by FDASIA section 707, now deems a drug to be adulterated if "…it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection."Basically, if they can't see what they want, when they want, that product is adulterated.
The categories defined in the guidance include 1) Delay of inspection (pushing back an inspection, holding up during an inspection, delaying of getting records), 2) Denial of inspection, 3) Limiting an inspection (limiting access, limiting photography, limiting access to records or the copying of those records, and limiting or preventing the collection of samples, and 4) Refusal to permit entry.
It may be worth the time to gain an understanding of this guidance and what constitutes the definitions in preventing access. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf
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