Q10 W12

Question 1

FDA Auditors and Consultants must be a part of the FSMA third party program in order to conduct on site audits.

True
False

Answer 1

False

Question 2

Full Inspections and Abbreviated Inspections are types of FDA audit inspections.

True
False

Answer 2

False

Question 3

Profit seized or given up as consequence of noncompliance is called…

Debarment
Consent Decree
Seizure
Disgorgement
Injunction

Answer 3

Disgorgement

Question 4

_______________________ is a step by step guidance on performing inspections.

Six-System Inspection Model
Establishment Inspection Report
Compliance Program Manual
Notice of Inspection
Inspection Observation Notice

Answer 4

Compliance Program Manual

Question 5

If the FDA is looking to get an update on your firm’s cGMP compliance they will opt for a______________________

For Cause Inspection
Reinspection
Abbreviate Inspection Option
Full Inspection Option
Directed Inspection

Answer 5

Abbreviate Inspection Option

Question 6

FDA inspections occur for manufacturing and pharmaceutical facilities 2x a year.

True
False

Answer 6

False

Question 7

If your firm has a history of satisfactory compliance how many Quality Systems are up for inspections?

Up to 3
Up to 4
All
One
Up to 5

Answer 7

Up to 3

Question 8

You have up to _____________ to respond to the FDA 483 with your corrective actions.

28 days
30 days
15 days
10 days
120 days

Answer 8

15 days

Question 9

In order to maintain quality, you have to _______________________.

Answer 9

continuously improve processes

Question 10

Give a brief summary of a typical FDA audit from start to finish.

Answer 10

The investigators will arrive at the site. They may announce their visit beforehand or it may be a surprise. They will present all the necessary documents and reasonings. The company will greet the inspectors. The agenda will be explained and the investigators will request the necessary data. They will tour the facility, observe processes, ask questions, and take photos. At the end of the inspection, a meeting and a review of the findings will be held. The firm will respond to the observations through things like corrective actions. A Notice of Inspectional Observation (FDA-483) will be presented at the end. A follow-up inspection may be necessary for companies that receive a VAI or OAI.