On August 6th, FDA investigator - Megan Haggerty - issued this 483 to a Rhode Island biologics manufacturer. The first observation was about bioreactor contamination:
On August 22nd, the biologics innovator responded. It's strange because the response is marked, "Confidential" yet the FDA released this to the public via their website.
Dissatisfied with the response, the FDA issued a warning letter on March 22, 2013.
And this was such a big deal that management had to address contamination issues at the Q1 2013 conference call. When queried by an analyst, management said:
I can't say for certain that this was their problem, but we're seeing a lot of this process piping going directly to drain. See the (badly hand-drawn) illustration below. The left drain pipes process fluids directly to drain. The right drain has the process piping that stops just above the drain.
Question: Which is floor drain design is better with respect to mitigating bioreactor sterility?
1. The firm's investigations into Soliris █████ microbiological contamination events are inadequate.
On August 22nd, the biologics innovator responded. It's strange because the response is marked, "Confidential" yet the FDA released this to the public via their website.
Dissatisfied with the response, the FDA issued a warning letter on March 22, 2013.
And this was such a big deal that management had to address contamination issues at the Q1 2013 conference call. When queried by an analyst, management said:
Let me start by saying, yes, we have identified the microbial agents that were the contaminating factors. They're soil-based organisms. We believe that they were probably introduced from someone's shoes, clothing, hair and probably related to an improperly functioning floor drain that has now been reengineered. And as I mentioned also on the call, we've also changed the way we clean and store our bioreactor equipment. And I think we have now -- we believe we've adequately addressed both of those issues.
I can't say for certain that this was their problem, but we're seeing a lot of this process piping going directly to drain. See the (badly hand-drawn) illustration below. The left drain pipes process fluids directly to drain. The right drain has the process piping that stops just above the drain.
Question: Which is floor drain design is better with respect to mitigating bioreactor sterility?
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