Any difference in FDA inspections since the risk-based approach was announced?

[Scott Catron]

Any other drug manufactures here? Anybody notice a difference in inspections since the risk-based approach was announced last February ( http://www.fda.gov/cder/gmp/ )? Our experience may show that they have. We had an inspection August 2002 and then another this April. This was unusual in that we are usually visited every two years. But it was also unusual in the results of the audit.

Our pharmaceutical products (topical antimicrobials - stuff like the alcohol sanitizing products in the grocery stores and the iodine solutions used in hospitals) are low-risk products, if one were to rank the chance of anyone getting hurt during the use of all pharmaceutical products available, but we've been treated in the past like these things are getting injected into brain tissue.

That seemed to change in April. The inspector was here a week and didn't even issue a 483. We've never had an FDA inspection without a 483. We were shocked. There were a couple issues that could have been justified in a 483, but his overall impression was that we were doing fine and no 483 was required.

Anyway, just wanted to see if anybody else has noticed a difference.

Scott

(I apologize if this is a bit beyond the scope of these forums - I haven't found a similar site to discuss FDA issues such as this)

[Aaron Lupo]

Scott we are not a drug manuf. we Sterilize, Package and Test Medical devices and we were inspected twice by the FDA last year after not being inspected in about 5 years. We did receive a 483, I know the inspector was only doing her job but she really lacked people skills!

[Scott Catron]

Originally Posted by ISO GUY

Scott we are not a drug manuf. we Sterilize, Package and Test Medical devices and we were inspected twice by the FDA last year after not being inspected in about 5 years. We did receive a 483, I know the inspector was only doing her job but she really lacked people skills!

Can't say we've ever had a problem with people skills. Bullheaded, yes, but not people skills.

Scott

[Isolytica]

your comments are interesting about the inspector's. i have always thought that the inspector's were doing their jobs well. it's just that many people do not understand the basis for their questions and misconstrue their comments. also everyone has a bad day or two. i am not an inspector, just someone who has sat thru many inspections for high and low risk products.

[Aaron Lupo]

Originally Posted by Isolytica

your comments are interesting about the inspector's. i have always thought that the inspector's were doing their jobs well. it's just that many people do not understand the basis for their questions and misconstrue their comments. also everyone has a bad day or two. i am not an inspector, just someone who has sat thru many inspections for high and low risk products.

If you lok back I stated she was doing her job, now the lack of people skills comes into play when the inspector comes out and states "I don't think you know what you are doing" to one of our employees. Tell me how can that be misconstrued????

[Isolytica]

Iso Guy, yes you did say "inspector was only doing her job'. And I continue to believe they are doing it well, as I wrote.

However, the quoted comment of the inspector, I suspect, was not the first from her during the particular interview. There had to be interplay that led up to that conclusion.

The inspectors are allowed to judge the qualifications of the interviewees. I doubt that the comment was made without reason. Albeit, the reason could have been obscured by nervousness that led to insufficient answers, etc.

Actually, I think you have answered your own question. Because you have indeed misconstrued the comment as hostile and intentional. I would view the comment as one of frustration or exasperation, which is how it should be viewed. Only the people witnessing the events can really tell though. And I was not a witness, so please do not place me in the position of defending the inspector simply because I think the job they do is tough and that they do it well. I would look into why the comment was made from the company side, and try to alleviate any concerns instead of focusing on the inspector. jmho

Anyway hope you had a fine holiday and good luck on future relations with the FDA.

[Aaron Lupo]

Ok lets step back and take a deep breath here! Never once did I say the Inspector was doing her job poorly. Yes, I did say she lacked people skills, which I will stand by. I admit the peson she made the comment to was rather nervous, however, that does not give the Inspector the right to tell the person they don't know what they are doing, JMHO, but comments like that she be kept to herself or discussed with Management. The fact remains this person is very capable at what they do.

Never once did I ask you to defend the actions of the Inspector you did that on your own. I agree they do have a difficult job, however, I will disagree that all FDA Inspectors do their jobs well. In your experiences you may have had a very good Inspector, in our case this one Indvidual I felt lacked people skills and the comment should have been made to Management and not the person. Management did look into why the comment was made and guess what, they agree that the person is very capable at what they do. So lets just agree to disagee on this!