The following are considered when reaching a decision:
- Good manufacturing practice violations
- Violations supported by the collected evidence
- Significant deviations
- Existing laws, regulations and guidance surrounding identified issues
- Compliance history of the firm
- Previous reports (good or ongoing problems)
- Corrections the firm is proposing -- and the adequacy
- Risks associated with the product (is it low or high)
Lesson status: Incomplete (0% done)
Topic: page 2 of 3 (Lesson: page 4 of 35)