Quick Summary of 483 Observations

[Deleted]

I made a quick summary of the 483 observations made at Catalent Pharma Solutions, Llc in Saint Petersburg, FL.

This place is supposed to be a so called "Center of Excellence?"  These observations and deficiencies are a total and unequivocal embarrassment.   If you want to know specifics regarding each observation you will have to refer to my other thread where I have posted the photos. 

The seemingly incompetence and/or lack of concern, sloppiness, neglect, negligence, flat out not doing their jobs, whatever you want to call it, is shocking for such a "Center of Excellence."

This is a flat out disgrace, and I am not going to be surprised if these deficiencies and observations don't take a long enough time to be corrected and reinspected that we are going to be 6 months or more down the line with Rayaldee.

Dina Kostakis, General Manager of Catalent Saint Petersburg, FL: 

"We want to showcase what we've done with operational excellence."  "When employees walk through the doors of Catalent Pharmaceutical solutions plant in St Petersburg Florida they have a mission: to get better everyday."

Are you serious is this what this lady just said in this interview, and then years later we see these sloppy, sloppy work QA and Control issues?

If they are "getting better" everyday with "operational excellence" I would hate to see what these people would produce if they didn't try to "get better everyday." 

Entertain yourselves with this interview:  

www.processexcellencenetwork.com/lean-six-sigma-business-transformation/videos/creating-a-continuous-improvement-mindset-intervie/

I can tell you board members this:  


If I performed my job as carelessly, negligently, and incompetently and as some of these people at Catalent obviously do, people would die as a result.

SUMMARY OF OBSERVATIONS AND DEFICIENCIES NOTED IN THE FDA FORM 483 AT CATALANT PHARMA SOLUTIONS, LLC

SAINT PERTERSBURG, FL 33716-1016

ISSUED 3/25/2016

Observation 1:
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Observation 2:
An NDA Field Alert Report was not submitted with (Blacked out) of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

Observation 3:
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel.

Observation 4:
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Observation 5:
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, strength, identity, quality or purity of the drug product.

Observation 6:
The responsibilities and procedures applicable to the quality control unit are not written and fully followed.

Observation 7:
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.

Observation 8:
Component weighing operations are not adequately supervised.

Observation 9:
The control systems necessary to prevent contamination or mix up are deficient.

Observation 10:
Employees are not given training in the particular area they perform as part of their function.

Observation 11:

Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components, in process materials and drug products conform to appropriate standards of identity, strength, and purity.

Observation 12:
Procedures describing the calibration of instruments, apparatus, gauges, and recording devices are deficiently followed or written.

Observation 13:
Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance.

Observation 14:
Written procedures have not been developed for the receipt and evaluation of post marketing adverse drug experiences.

[onefreetrajectory]

Thanks for posting. I agree with your sentiments. I think the FDA has been rather nice with them for some time on these unresolved issues. I also will be very, but happily surprised if we get the 30 day go ahead rather than 6 months for reinspection. It's almost like the FDA said "seriously? You guys have the balls to ask to make a new product here when you cannot even make the ones you already do correctly and you cannot follow procedures"

[Deleted]

That seems to be exactly what the FDA was saying to Catalent.  I mean it seems just like you said, "Really you want want to approve this when you are handing to us on silver platters all these negligent discretions we are observing in your operations?"

I mean I am no expert in this field or even a novice, but I do have some work ethic and conventional wisdom on how things should  operate, and I know mistakes will be made and they can gig them on anything, but it seems to me that these were excessive and elementary.

[stcks]

What is frustrating to me about this whole process is that the inspection of Catalent started on the 14th and finished on the 25th for approval date on the 29th.

That just strikes me as a very short timeframe with some of these deficiencies going back to 2013 (if not even older than that). Is there not a better way for the FDA to handle this?

I doubt that any of these deficiencies were unknown to Catalent on the 14th. Did else anyone outside of Calalent or FDA know of these deficiencies at that time? And if the answer is no why not? (Dr. Trusts job now)

If this type of information was public would not have OPKO had applied pressure to resolve these deficiencies before the 29th. And why is not any of the current drugs being stopped?

From the sounds of it this is really the only manufacture that can produce Rayaldee in this format.

From the way that this is been handled so far the only persons that has been hurt is the ones that has no control or say so over any of these issues. The shareholders of OPKO!

Calalent - no big change. No change in pps, sales, can still manufacture all the current products. (Of which all have the same problems that Rayaldee would have if it was approved)

FDA - just have to fight with another evil drug company.

[Deleted]

You are exactly right the only ones who have burn negatively affected by this pure bred 100% incompetence are the OPK shareholders.

[Deleted]

It's going to be a long, long time before R is on the market. Different mfg, build our own plant, fix the old plant (don't think so, it's cultural)?

[Deleted]

Thanks to Frostbite for this summary. I read the letter yesterday but seeing it in summary form heightens the impact of Catalent's negligence. To potentially complicate matters, as I recall, part of the deal with Catalent for Rayaldee was the use of new gel cap technology providing for time release (gels are usually utilized to achieve instant drug release). Not sure if this is yet another potential hiccup given the broad scope of the company's fundamental problems apart from introducing a new technology.

So what does OPK do now? It doesn't make much sense to sue Catalent unless they determine they have to start from scratch in sourcing production for Rayaldee. Doing so would only push the introduction further out. But there is no question, at least in my mind, that OPK has suffered substantial economic damage directly attributable to Catalent's intentional negligence. OPK has entire staffs (sales, distribution, etc) that are left twiddling their thumbs. One possibility would be to reach an agreement with Catalent about the cost of the damages and true it up through reduced production charges once they get their act together. After so much anticipation focused on the March 29th date, this has been a real buzz kill.

[Deleted]

Semi, it's prolly not going to delay the sales of the drug.. They intended to start in H2, so not much/any damage there.

C L

[opkfrostfan]

These are really minor infractions which is why they can proceed without interruption for all approved drugs. They are even more minor when compared to the symptoms of CKD. No sense of proportion.