FDA Orders Shutdown Of Castleberry Food Plant

Castleberry

The Food and Drug Administration has shut down Castleberry’s food plant in Augusta, Georgia. In July 2007, Castleberry went through a massive recall of canned chili linked to botulism poisoning.

Castleberry Foods produces Natural Balance Eatables for Dogs. (Natural Balance also recalled cans of Natural Balance Eatables for Dogs for possible botulism risk during the canned chili recall.)

The suspension of its operating permit and shutdown was ordered on Friday, and a FDA spokesperson said that part of the processing lines used to make food were not being operated properly and this could result in underprocessed cans of food.

Here is the FDA press release:

In July 2007, over 80 types of canned food products and 4 types of dog food produced by Castleberry Foods were recalled due to possible contamination with Clostridium botulinum.

FDA issued an ‘Order of Need for Emergency Permit’ to the firm at that time. This means that the firm was not able to ship its products in interstate commerce until it received a permit from FDA. The agency issues an ‘Order of Need for Emergency Permit’ if it determines that a firm does not meet requirements of the regulations pertaining to the manufacture of thermally processed low-acid foods or acidified foods, such that the safety of the food is in question.

FDA believes the company remedied the previously existing food safety problems and the processing procedures will result in a finished product that does not present a health hazard.

The firm requested an emergency permit and FDA issued an emergency permit after a review of a firm’s documented corrective actions and processing procedures. In September 2007, FDA issued a permit that allowed the firm to ship products that were processed using the firm’s machinery (the vertical still retorts) not associated with the recalled product. None of these retorts was believed to be linked to the previous C. botulinum contamination.

During a recent inspection of these processing lines FDA found that the vertical still retorts were not being operated in a manner as required, raising the possibility that some cans processed in these retorts could be under-processed. On March 7, 2008 FDA sent a letter to the company suspending the temporary emergency permit.
No products have been identified as contaminated. FDA has asked the firm to verify the safety of all products produced since the emergency permit was issued.

Source: WJBF

(Thanks menusux)

10 Responses to “FDA Orders Shutdown Of Castleberry Food Plant”

  1. Nell Liquorman says:

    Just because they have not identified any deadly products does not mean that none were produced.

    The previous problem was identified as equipment malfunction. Now they seem to be saying that equipment may not be used properly. So, which way is it?

    As health editor for National Pet Press, I tried without success to get some answers from Natural Balance concerning their pet foods. When you get no answers, is there even more reason to worry?

    Now should the public question the answers given us by Castleberry’s.

    Just how much should we trust the FDA? Are there enough inspectors? How effective are they at keeping the food supply safe for humans or pets?
    The public may not get what they don’t demand.

    Isn’t it time for government agencies and corporations to step up to the plate and make our foods safe. Could they start by stopping so many imports of ingredients or the canning of products in other countries? There are many places that do not have a fraction of the safety measures in place that exist here. With corporations going off shore for cheaper labor and cheaper products, we must worry. It is all the FDA can do to protect products produced here, and Castleberry’s is a fine example.

  2. CGP says:

    Why the public won’t demand food safety is beyond me. There’s been a concerted effort by our government to cut the budget for the FDA for a very long time. Our imports are up; inspections are down. Despite the many safety issues, companies are still lining up to do business in China. Until we stop buying their junk, this will continue.

  3. Don Earl says:

    RE: “There’s been a concerted effort by our government to cut the budget for the FDA for a very long time.”

    Nonsense. The FDA’s budget has increased by on the order of 10% per year for the past 2 decades and is currently at over $2 billion.

    Do you have any concept how much money is $2 billion?

    It’s enough to hire 35,000 inspectors at $60,000 per year!

    If each inspector conducted 8 inspections per day, 5 days per week, 50 weeks per year; the FDA would conduct 70 million inspections annually.

    I the last house I built, there were on the order of 30 inspections from foundation to finish. I’ve talked to building inspectors that have made 35 inspections in a day during peak building months.

    If we can do that with a house, where worst case might result in property damage, why can’t we do it when over 300,000 Americans are hospitalized for food born illnesses, and 5,000 of them die, EVERY SINGLE YEAR?

    I don’t mean to be unkind, but I can’t help but be disgusted by the mo’ money crowd. We don’t need to spend more money. What we need is a better return on our investment through better management.

  4. 5CatMom says:

    The president of Hallmark Westland, Mr. Steve Mendell, testified before the House Committee on Energy and Commerce this morning. He said that there were 4 full time inspectors at his plant.

    So how many USDA inspectors does it take to identify downer cattle and keep them out of the food supply?

    The hearing will resume after a voting break. There are two more panels. The FDA/USDA is last.

    http://energycommerce.house.go.....dule.shtml

  5. DW says:

    To Nell L.
    “The previous problem was identified as equipment malfunction. Now they seem to be saying that equipment may not be used properly. So, which way is it? ”

    The answer is most likely both. I work in a field regulated by the FDA. What happens with some companies is that they simply aren’t organized. They are not operationing under cGMP rules (current Good Manufacturing Practices).

    What it means is that people are supposed to be trained, all training, all production procedures, all quality procedures, are supposed to be written down and followed by everyone. There are supposed to be processess (how to do something) and SOPs (written instructions that describe the ‘how to things’) that define and set standards for every action performed by every employee and every piece of equipment.

    When a company has bad or no processes all the way around it shows up everywhere. If they don’t have processes defining how to do something right then, conversely, there is no definition of how to tell if something is malfunctioning (equipment failure) or how to tell if someone is doing something wrong (operator error). On top of that, if there is no process for testing people and equipment AND fixing deficiencies …. well then you end up with a company that has problems all over the place and the problems aren’t noticed and aren’t fixed while they are controllable. (For example, it’s better to catch a problem early and throw out a single batch than to catch it late and have to recall 6 month’s worth of food …but that takes management dedicated to quality control and I bet this company doesn’t have that.)

    At the core, this company has probably has bad processes. The FDA gave them the benefit of a doubt on the equipment malfunction. At the same time the FDA would have also told them to fix all the processes that touch on the equipment. The company probably said yes, yes, but did not or was not able to fix everything.

    At that point the FDA had this company on the top of their list. They came back and checked. Okay, so at least the company isn’t using the bad equipment. However, the company had not really fixed the problems they have with their processes. The FDA nailed them on it.

    The FDA system is working properly …as defined by the law. The company is not. Sure it would be nice if the FDA had more people and could do more checks, more often but the problem here is not the FDA — it’s the company that can’t figure out how to follow cGMP rules.

    If we want different/better laws and a more pro-active FDA, then I guess that is up to us to demand it.

  6. Don Earl says:

    RE: “The FDA system is working properly …as defined by the law.”

    I would urge anyone who actually believes that to a little time to review some of the provisions of Title 21 of the US Code.

    http://www4.law.cornell.edu/us.....01_21.html

    As defined by law, the system is broken. You may check the recalls listed in various sections of the official FDA site to see just how broken it is. If the system were not broken, there would be no recalls.

  7. Don Earl says:

    RE: “The FDA system is working properly …as defined by the law.”

    I would urge anyone who actually believes that to take a little time to review some of the provisions of Title 21 of the US Code.

    http://www4.law.cornell.edu/us.....01_21.html

    As defined by law, the system is broken. You may check the recalls listed in various sections of the official FDA site to see just how broken it is. If the system were not broken, there would be no recalls.

  8. DW says:

    Don,

    You are confusing the FDA system with the systems inside the manufacturing plants. I spend all day, every day doing things to ensure my company is following Title 21 plus the rules set by European, Asian, and South American analogs of the FDA. I have have dozens of co-workers who also spend all day checking and double checking that every step and every piece of equipment is in compliance. When we have a failure, it our systems, not the FDA rules that are out of compliance. The goal is to aim for perfection but test, test, and test so that equipment failures and human mistakes are caught so early that it does not affect anything produced. That goes a long way to preventing anything bad from going out the door. However, there are additional processes in place to test the finished product and to track what has gone on to customers so that at each step of the way things can be recalled …recalls are very, very rare for us. I can’t think of any in the 5 years I’ve been at my current facility.

    It’s up to the manufacturing company to be in compliance. FDA are the rule makers and the enforcers only. What the FDA needs is more people and a bigger budget so they can do a better job at the enforcement side of things. The rules are already there. The industry I’m in gets audited continuously … every month there are regulatory agencies from all over the world, from our state, plus from our customers just looking over our facility and our paperwork to make sure we are legal and in compliance.

    If the FDA had more people, industries that are considered less critical …like pet food and people food would have more inspections. They certainly should have them anyway because the law allows for it. Unfortunatley the FDA’s budget does not. Much as we’d rather see less of the FDA at our facility, we recognize that it’s a good thing for them to be here so often. They force constant improvement without which the bean counters would likely be sticking with outdated technology and processes because it’s cheaper.

    Well, that’s where food is at now. The companies need to be hit harder to make their management put $ and people into compliance. Right now it has to be a friggin disaster before some companies give a real effort to quality and compliance. Going out of business is cheaper for them than true compliance. That has to stop. Companies in my industry can’t even open up until they have months and months worth of data proving they are in compliance. I’d like to see the bar raised for all food products, especially since we are mixing in so many foreign ingredients.

  9. Gindy says:

    Thanks, DW, for some sanity in this discussion.
    $2 billion is not enough to inspect the hundreds of thousands of articles that are sold each and every day to all of us. The FDA is not funded enough, in fact in real dollars the funding is less than it was in the 70’s but we have a 1000% increase or more in products over that same time period.
    Industry hacks are now at the head of most of the departments set up to inspect industry. Mining, health, food safety, EPA almost all of them have an industry connected lobbyist or actual company office in charge of it.
    Now think about that for a second… do you want the guy who used to be in charge of menu foods as head of the FDA? That’s about the level of connection that exists now a days.

  10. Terry says:

    We are better off with the FDA underfunded until we get some better leadership in this country. We will never get their resources properly applied until then.


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