When Documentation Fails

Purpose:

This brief reading is intended to demonstrate the impact of poor documentation practices. Below you will find portions of a real letter, written by the Food and Drug Administration, to a pharmaceutical company. The entire letter can be found on the FDA website at http://www.fda.gov/cder/warn/2004/wl320-04-03.pdf. This letter cites violations found at this company, many of which relate to poor documentation practices. (There are more violations cited in the letter than are shown here.)

Note that there are blank spaces in the letter. This is because the FDA deletes certain proprietary information from warning letters before posting them on the web.

Activity:

Read the warning letter and answer these questions:

• What mistakes did the company make with regard to documentation?
• What was the decision of the FDA regarding this company? What impact will this decision have on the company?

The printable version of this document.

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