Audits are the cornerstone of a QMS.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.
The agency has issued its list of the most common inspectional observations for FY 2017.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
If your firm does not have an MDR procedure, FDA will find out.
How you respond to Form 483 observations matters.
Wouldn’t you like to stop routine FDA inspections and forego pre-approval inspections?
Are you performing preventive maintenance?
Have repeat observations from a previous inspection? Expect a warning letter.