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| Letter from the Editor |
| Did You Know? |
| Thought of the Week |
| IJPC now on Facebook and Youtube |
| Looking Back |
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| The FDA and Pharmacy Compounding
FDA Form 483, Part 4 |
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Contents
Form FDA 483 (Highlighted sections in this Newsletter)
1.1 Header Information
1.2 Observations
1.2.1 Annotation
1.3 Signatures
1.4 Reverse Side
1.5 Addenda/Amendments
FDA Form 483
The content of the form may be handwritten, typed, completed in a PDF file and printed, or completed via the FDA's computer system.
Reverse side
The reverse side of the form has this text:
The observations of objectional conditions and practices listed on the front of this form are reported:
1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.
Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC §374(b)) provides:
'Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.'
Addenda/amendments
It is possible that an error is discovered by the inspector(s) after issuing the 483. If the 483 was generated via Turbo EIR, then an amendment is created within that system. Else, an addendum is created. If possible, the investigator(s) will personally deliver the addendum/amendment to the firm.
Addenda/amendments are not normally used for adding observations to a 483 after the inspection has been closed out and the investigator(s) have left the premises.
Public access to Form FDA 483s
Form 483s are available under the Freedom of Information Act, but may be redacted to remove non-public information. The FDA publishes select 483s on their website at this location:
Miscellaneous: FOI Reading Room
Some third parties query the FDA and publish a listing of Form FDA 483s issued since 2000.
As of 21-Nov-2009, the FDA is seeking input from the public "on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly." Responses from the public can be submitted on the FDA's website.
Next week: Observations and Trends.
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Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Did You Know ...
...that Billy Graham said the following?
"America's founding fathers did not intend to take religion out of education. Many of the nation's greatest universities were founded by evangelists and religious leaders; but many of these have lost the founders' concept and become secular institutions. Because of this attitude, secular education is stumbling and floundering."
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Thoughts of the Week (On education since school starts soon)
"Educate men without religion and you make them but clever devils." (Arthur Wellesley)
"Education is the knowledge of how to use the whole of oneself. Many men use but one or two faculties out of the score with which they are endowed. A man is educated who knows how to make a tool of every faculty - how to open it, how to keep it sharp, and how to apply it to all practical purposes." (Henry Ward Beecher)
"Education is what survives when what has been learnt has been forgotten." (B.F. Skinner)
"Education - The only thing one is willing to pay for, and hopes he doesn't have to work for it." (Anon)
"What is defeat? Nothing but education, nothing but the first step to something better." (Wendell Phillips)
"The great end of education is, to discipline rather than to furnish the mind; to train it to the use of its own powers, rather than fill it with the accumulations of others." (Tryon Edwards)
"All who have meditated on the art of governing mankind have been convinced that the fate of empires depends on the education of youth." (Aristotle)
"Personally I'm always ready to learn, although I do not always like being taught." (Winston Churchill)
"Nowadays, kids have to go to college. How else are they going to get a good high school education?" (Anon)
"The primary concern of American education today is...to cultivate in the largest number of our future citizens an appreciation both of the responsibilities and the benefits which come to them because they are American and free." (James Bryant Conant)
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Looking Back
Santa's whiskers,
Need no trimmin'
He kisses kids,
Not the wimmin!
Burma-Shave
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