➡️ If you are a drug manufacturer or medical device, who manufacture of drug or device for the US market can be always ready for inspection of USFDA. Hence, it is a best practice to always be prepared and up to date with FDA regulations.
➡️ If you want breathe a little easier at your work place then always be prepared yourself against inspection.
➡️ Often USFDA inspection arrived with no advance warning. It just like that you will go to your company one day for your work and find an inspector waiting to get started an inspection.
Following facilities that come under FDA inspection:
- Drug manufacturers
- Device manufacturers
- Food processing facilities
- Blood banks
- Animal study conducted Laboratories
- Dairy farms etc.
➡️ Based upon inspection purpose and timing, FDA may conduct any four different type of inspection. Intention of each type is protect the public from unsafe products, but expectations of each type of inspection are different.
Let's take a look at the four types:
1.PRE-APPROVAL INSPECTIONS:
When: A company submits an application to FDA for marketing a new product.
Why: To verify the data you have submitted in your application and to confirm that your facility is suitable for drug manufacturing.
How: By announcing five calendar days in advance. If your firms having violation history then you may get no notice at all.
Outcome: Inspectors will recommended for or against FDA approval
➡️ Often facilities may not get pre-approval inspection but the FDA determines this with risk based approach and looking at product facility and process risk.
2. ROUTINE INSPECTIONS:
When: To be expected every two years.
Why: To assess whether your company is still following product quality and compliance.
How: You may get five calendar days advance notice or unannounced.
Outcome: If you have zero 483 or warning letter then you continues export your product in to US market. If they find any non compliance issue then they will come back sooner and possibly to be conducting follow-up or "for cause" inspection.
3. COMPLIANCE FOLLOW-UP INSPECTIONS:
When: if your company was issued 483 observations or any warning letter.
Why: To inspect and verify the action you have taken in response to 483 observations and also to check your corrected actions of previous violations.
How: Never have get advanced notice of this type of inspection.
Outcome:If your company responded adequately and take a corrective actions against previous violations then your company compliance all 483 observations otherwise FDA issue import ban.
4. FOR CAUSE INSPECTIONS:
When: An issue reported to the FDA from consumers or employees and especially in the case of any significant harm or a product recall.
Why: To find cause on the particular issue in depth and to find out there will be any significant impact on product SISPQ.
How: You will not get advance notice of this type of inspection.
Outcome: Either your firm compliance without observation or getting strict/prohibitory action against your firms.
Will you know when FDA is coming?
➡️ If your answer is no then always be prepare like fire fighters.
➡️ FDA inspection of a foreign establishment is mainly pre announced two to three months in advance to allow time for travel and other necessary arrangements. Firms which have a history of violative inspections will not be granted this luxury.
Very informative...keep posting.
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