In this article we will outline the importance of having an FDA approved manufacturer that follows steps and procedures that ensure the safety of companies, the end consumer, as well as, the manufacturer of the product.
Most startup companies don't even recognize what guidelines are in place that might limit or benefit the product; and too often the products manufacturer doesn't follow guidelines outlined by the FDA.
What does this mean for companies? In 1996 the FDA announced a recall of all products containing a certain company's unpasteurized apple juice.
This recall was initiated after 13 reports of E.
coli were linked to the company's product of unpasteurized apple juice.
The Washington Department of Health, Centers for Disease Control and Prevention, and other public health agencies conducted an epidemiologic investigation into the outbreak.
It was found that there were more than 65 individuals who were infected with E.
coli.
Of the reported cases, more than a dozen developed Hemolytic Uremic Syndrome, and one child died.
The FDA began investigating the company's manufacturing procedures and found numerous health and safety code violations that may have contributed to the spread of E.
coli.
The FDA also found that the company's plant accepted decayed fruit from suppliers.
In 1998 the company was indicted and held criminally liable for the 1996 E.
coli outbreak.
They plead guilty to 16 federal criminal charges and agreed to pay a $1.
5 million fine.
In correspondence with the outbreak, the company began pasteurizing its juices, and the federal government now requires warning labels to be placed on all unpasteurized fruit and vegetable juice containers.
When choosing a manufacturer it is important to obtain knowledge about the facility and the procedures that are in place to ensure the safety of everyone.
It was interesting to find out that in the last two years there have been new implications from the FDA regulating the manufacturing of liquid dietary supplements.
The new laws and regulations of the FDA can be found in Title 21, Section 111.
In 2011, all manufacturers of liquid dietary supplements are required to have the new laws and regulations in place.
The new laws will certainly sift out the good from the bad of liquid manufacturing plants.
Those that can't comply with or refuse to follow the new laws will run into problems with the FDA shortly.
The laws are very tedious with step by step instructions from the time the components enter the manufacturing plant to when they leave the plant.
There is so much information in Title 21, Section 111, that it would be too difficult to outline it all.
To summarize it, steps and procedures for every step of the manufacturing process must be in place and logged every step of the way.
This is very time consuming and very expensive to maintain.
Tropical Resources, a midsized manufacturer and co-packer of liquid dietary supplements is a great example of having GMP's in place and being in good standing with the FDA.
Implications of the new laws are in place and have only added to the reputation of the company.
At this company, being FDA approved means that they follow every guideline without exception.
It is relieving to know that as the manufacturer of many liquid dietary supplements, they produce the highest quality products due to the steps and procedures that are implemented for each company's product.
For each company currently contract manufacturing their product, I would urge you to ask your manufacturer if the new laws have been implicated and are currently in use.
Protect yourselves and those consuming the product by ensuring that the proper procedures are being used to manufacturer your product.
Most startup companies don't even recognize what guidelines are in place that might limit or benefit the product; and too often the products manufacturer doesn't follow guidelines outlined by the FDA.
What does this mean for companies? In 1996 the FDA announced a recall of all products containing a certain company's unpasteurized apple juice.
This recall was initiated after 13 reports of E.
coli were linked to the company's product of unpasteurized apple juice.
The Washington Department of Health, Centers for Disease Control and Prevention, and other public health agencies conducted an epidemiologic investigation into the outbreak.
It was found that there were more than 65 individuals who were infected with E.
coli.
Of the reported cases, more than a dozen developed Hemolytic Uremic Syndrome, and one child died.
The FDA began investigating the company's manufacturing procedures and found numerous health and safety code violations that may have contributed to the spread of E.
coli.
The FDA also found that the company's plant accepted decayed fruit from suppliers.
In 1998 the company was indicted and held criminally liable for the 1996 E.
coli outbreak.
They plead guilty to 16 federal criminal charges and agreed to pay a $1.
5 million fine.
In correspondence with the outbreak, the company began pasteurizing its juices, and the federal government now requires warning labels to be placed on all unpasteurized fruit and vegetable juice containers.
When choosing a manufacturer it is important to obtain knowledge about the facility and the procedures that are in place to ensure the safety of everyone.
It was interesting to find out that in the last two years there have been new implications from the FDA regulating the manufacturing of liquid dietary supplements.
The new laws and regulations of the FDA can be found in Title 21, Section 111.
In 2011, all manufacturers of liquid dietary supplements are required to have the new laws and regulations in place.
The new laws will certainly sift out the good from the bad of liquid manufacturing plants.
Those that can't comply with or refuse to follow the new laws will run into problems with the FDA shortly.
The laws are very tedious with step by step instructions from the time the components enter the manufacturing plant to when they leave the plant.
There is so much information in Title 21, Section 111, that it would be too difficult to outline it all.
To summarize it, steps and procedures for every step of the manufacturing process must be in place and logged every step of the way.
This is very time consuming and very expensive to maintain.
Tropical Resources, a midsized manufacturer and co-packer of liquid dietary supplements is a great example of having GMP's in place and being in good standing with the FDA.
Implications of the new laws are in place and have only added to the reputation of the company.
At this company, being FDA approved means that they follow every guideline without exception.
It is relieving to know that as the manufacturer of many liquid dietary supplements, they produce the highest quality products due to the steps and procedures that are implemented for each company's product.
For each company currently contract manufacturing their product, I would urge you to ask your manufacturer if the new laws have been implicated and are currently in use.
Protect yourselves and those consuming the product by ensuring that the proper procedures are being used to manufacturer your product.
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