Talk:Form FDA 483

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Some thoughts[edit]

I have massive conflicts of interest with the content of this article, so it's probably best if I don't edit it directly.

1. This page should probably be moved to Form FDA 483, since that's the official title of the document. The most common name (at least in my experience) is just "483" but that's obviously taken.

DONE! --Kentmoraga (talk) 12:02, 5 April 2010 (UTC)

2. The article should probably at least hint at the language on the back of the form from the FD&C Act, since in some cases it's a legal requirement to issue the form. Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC374(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." (quoted from the back of the form)

DONE! --Kentmoraga (talk) 12:02, 5 April 2010 (UTC)

3. It might be worth mentioning that the form is used in situations where it has no legal meaning (i.e. 361 HCT/Ps, foreign inspections) as a matter of business practice.

DONE! --Kentmoraga (talk) 12:02, 5 April 2010 (UTC)

4. The program frequently used to generate the form (since 2002 or so) is a source of many headaches and some explanation since it generates part of the text. Maybe worth mentioning in an encyclopedia article as part of the history of the document.

5. It might be worth mentioning that the content of the form is not only the observations of the person performing the inspection, it must be the opinion of the person performing the inspection. There has been some legal wrangling over what happens when the centers or management start meddling directly in inspections.

6. It might be worth referencing the Investigations Operations Manual (this section) which might also have some valuable tidbits that might be worth adding to the article, like annotation (currently only used for the medical device industry).

DONE! --Kentmoraga (talk) 18:43, 29 June 2010 (UTC)

Just as a random thing, the person doing an inspection is usually referred to as an "investigator" [DONE! --Kentmoraga (talk) 12:02, 5 April 2010 (UTC)] by FDA since Consumer Safety Inspector (GS-1862) is a specific, mostly obsolete, position title and most people doing inspections are Consumer Safety Officers (GS-0696). Doubt that anyone cares much. SDY (talk) 00:53, 23 January 2010 (UTC)