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FDA Rules and Regulations

The FDA (Food and Drug Administration) is a branch of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and medication.

Can the FDA legally inspects and cite a facility that is closed for upgrades, not operational and not producing.

The FDA is allowed to issue a citation, but if the company is not operational and was making upgrades that would have cured the violations then the company can provide some kind of proof to the administrative hearing officer and the violations be canceled along with the fines. The inspector does not have to wait to do the inspection; they have the right to do so if they are informed that the plant is closed. The FDA does not exercise that discretion properly and simply issue the citation because it is less work for them. The company can file an appeal on the violation and present evidence that not only was the company closed for business and not producing anything, but were conducting maintenance and repairs that cured the violations.

I found a fly in a jar of KRAFT Pimento cheese spread last night. I nearly swallowed it. I saved the fly & the spread. What should I do?

The Food and Drug Administration should be contacted and there is a customer contact number for Kraft that should be on the jar. These kinds of cases aren't usually pursued beyond getting the manufacturer to give some free product or money back. The law doesn't provide for any damages for what could have happened to the individual; only when something does happen is action taken.

How would I go about trying to get the FDA to ban a very dangerous drug that is way over used and causes permanent memory loss and severe anxiety and depression (It left me with Post Traumatic Stress Disorder and a 15 year span of amnesia.)

The FDA can be contacted by letter or lawyer letter warning of observations. Also, a person can have the local congressman pursue this complaint in helping with the agency.

We are a manufacturer and distributor of mid priced cutlery in the US. We manufacture of product in China. We are looking for a clear definition as to what the Chromium level needs to be in our cutlery blades in order to be compliant with the FDA regulations?

Under the FDA guidelines to qualify as being labeled stainless steel, the knives must contain a minimum of 11% chromium, which is what the FDA states.

I took a prescription pharmaceutical drug and developed permanent side effects even though the label said they were temporary. When does my statute of limitation clock start ticking regarding discovery of injury?

The statute of limitations would typically begin at the point where the person should have known about the injury. If there was any delay in seeking confirmation from a medical provider, the time would normally begin prior to actual confirmation. If it was not delayed in seeking confirmation, then it would begin when that person received actual confirmation.

Having the right information about the FDA can help individuals deal with difficult situations and make the right decisions. Ask Experts about the FDA and other related topics.
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