OK, after reading Brenton Weavers information, it appeared to me there was conflicting statements, FDA saying something is wrong, at least wrong enough to go thru all of the press release, etc and Evangers saying everything is fine. So I decided to contact FDA myself and ask them more about the conflicting information afterall Evangers is saying that FDA's statement had false statements in it. Well I got a response back from FDA late this afternoon. I am not posting the persons name who responded out of respect for them. This is FDA's response to my inquiry about the conflicting info we are receiving:
The firm had serious deviations form the mandatory provisions of 21 CFR parts 108 and 113, including lack of documentation of process adequacy and lack of processing filing with FDA for most of their processes. The firm was operating the retorts improperly (not venting), failing to record critical process information including initial temperatures, temperature recording devices were recording temperatures higher than the mercury-in glass thermometers. The firm's retort supervisors had not attended the required training schools.
As correctly stated in the press release, the firm is operating under an Order of Need for Emergency Permit, which means it cannot introduce or deliver for introduction in interstate commerce any of its low--acid canned pet food. The regulation does allow the firm to have a processing authority evaluate the processing of each lot for adequacy and to submit release requests in writing to FDA for specific lots.
Edited to add: I am cross-posting this at the other thread also.
And that takes us back, in a sense, to the Castleberry problem.
http://www.itchmo.com/fda-orders-shutdown-of-castleberry-food-plant-4880"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."
http://chronicle.augusta.com/stories/031108/bus_190511.shtmlMarch 11, 2008
"Federal concerns about the operation of food processing equipment inside Castleberry's Food Co. prompted this week's shutdown of the Augusta chili maker.
"Most of the plant's 330 employees did not report to work Monday because the U.S. Food and Drug Administration revoked the company's temporary operating permit.
"That permit was issued in September in the aftermath of a last summer's $35 million botulism recall.
"An FDA spokeswoman said the permit was revoked because inspectors found "deviations" in how some of the processing equipment was being operated.
""The deviations could have caused the food processed to be unsafe. Because under-processing by Castleberry in the past resulted in a botulism outbreak and because Castleberry was operating under an emergency permit, FDA revoked the emergency permit," said agency spokeswoman Stephanie Kwisnek.
"Castleberry's officials emphasized Monday that the current shutdown does not involve a new recall.
""We expect to have a quick resolution," said Dave Melbourne, Castleberry's senior vice president.
""We are working quickly and closely with the FDA to answer its questions and hope to resume production as soon as we've addressed them.""
Cross posted from the other thread.
