Any other drug manufactures here? Anybody notice a difference in inspections since the risk-based approach was announced last February ( (broken link removed) )? 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)
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)