USA

Question 1

What are FDA warning letters?

Answer 1

• A list of observations made during the inspection that is communicated at the conclusion of the inspection.
• › The observations are listed in descending order of importance
• Snapshot of observation noted, not an all inclusive list
• FDA inspector issues this

Question 1

What are FDA warning letters?who issues it?

Answer 1

• A list of observations made during the inspection that is communicated at the conclusion of the inspection.
• › The observations are listed in descending order of importance
• Snapshot of observation noted, not an all inclusive list
• FDA inspector issues this

Question 2

What is a Form 483 who issues it?

Answer 2

Warning letters
- Higher FDA officials have reviewed the observations and that a serious violation may exist.
- includes evidence collected to support observations and provides further explanation
FDA inspector or invite to district office

Question 3

How is GMP enforced and monitored in the USA?

Answer 3

FDA ensures quality of drug products are monitoring drug manufacturers to see if they are being complaint with cGMP regulations.
CFR - Code of Federal Regulations Title 21 - FDA
Minimum cGMP requirements would include the:
1) Methods
2) Facilities
3) Controls used in manufacturing
4) Processing
5) Packing of a drug product.