Homework 5 – Good Laboratory Practices
Go to:
https://www.fdalabelcompliance.com/letters/ucm182420
Summarize and comment on GLP violations by Continuum Health Partners in the warning letter.
- From the first paragraph, the inspections are conducted as part of which FDA program?
- The inspections are designed to check compliance with which regulation/s?
- From violation number 1, mention which personnel, or responsibility, was missing from Continuum and the responsibility of said personnel. Do not present too much details on #1. For violations 2-8, focus on more specific actions which are violative, rather than mentioning broad descriptions of violations.
- Within how many business days of the Warning Letter receipt is Continuum supposed to respond to the FDA issues?
- No references needed for this homework. Only cite references when you use journal articles or books.
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