Foothills Professional Pharmacy, Ltd of Phoenix AZ appeared on FOIA for the second time, but I’m not sure why, as there was no associated hyperlink to any action of document. It was dated 10/24/2018, so it was probably something closely related to its first-ever 483 which was issued that day. This is likely (but not certain to be) an Amended 483. More on that soon, I’m sure.
Millers of Wyckoff, Inc of Wyckoff NJ was issued an SBoP Referral Letter on 2/26/2019
Mayo Clinic Pharmacy of Rochester MN had its 483 Response Letter posted. Its Response letter addressed the five Observations that appeared in its 483 which was issued on 8/15/2018 and which I covered in my newsletter of November 27, 2018. It was quite a good response letter in my opinion.
Fallon Wellness Pharmacy, LLC of Latham, NY was issued two Letters on 12/18/2018. FOIA called the first document “Other Correspondence,” but for all intents and purposes, it looks like a typical SBoP Referral Letter. On the same date, this pharmacy was also issued an FMD-145 Letter, so congratulations to them for now knowing their recent inspection was considered “Voluntary Action Indicated.” (VAI)
Pharmacy Resources Incorporated of Denver, CO was issued its second 483 on 1/29/2019. It had previously received a 483 on 5/23/2017, which was the basis of a Warning Letter issued on 3/1/2018. For the current 483, seven Observations were recorded by a single CSO who was on site for nine days and who typed the entity as a Producer of Sterile Drug Products. Five of the seven Observations were deemed to be “REPEAT OBSERVATIONS.” This 483 appears ominous to me for a couple of reasons:
- FDA cannot represent itself in federal court. FDA must present DOJ with a compelling case to obtain a court order, because DOJ must be willing to “carry the ball.” DOJ doesn’t get interested until/unless there is evidence an organization is recalcitrant, but the hallmark of recalcitrance is “ignoring” previous notifications. REPEAT OBSERVATIONS are always such evidence.
- FDA assigned the inspection to a Consumer Safety Officer rather than a Field Investigator. CSOs are typically more experienced and seasoned in preparing cases for OAI and probably make better witnesses in legal proceedings;
Is it too late? Maybe not, but it would be very wise to engage an actual GMP expert immediately. Any organization that has had a WL followed by a 483 with one or more REPEAT OBSERVATIONS is a candidate for dire repercussions.
California Pharmacy & Compounding Center of Newport Beach, CA (503B) was issued its FIFTH 483 on 12/17/2018 and this 483 was amended on 12/18/2018. They had previously received their fourth 483 on 04/21/2017, their third 483 on 08/31/2016, a Warning Letter 06/17/2015 that was based on their second 483 issued on 10/17/2014, which was a follow up inspection just two months following their first 483 issued on 08/25/2014.
So, is this operation heading for OAI? Probably not. Why? It appears to me it’s because they’ve improved. They’ve never ever been cited for a REPEAT Observation. They addressed the findings of each 483 to the satisfaction of FDA on every return visit. I think they might serve as an example of FDA success. Here’s a table of their 483 results:
|8/25/2014||15 Observations||13 Pages|
|10/14/2014||3 Observations||3 Pages|
|8/31/2016||5 Observations||4 Pages|
|4/21/2019||7 Observations||5 Pages|
|12/18/2019||1 Observation||1 Page|
There is a second factor that could be playing into their steadily improving inspections. It could be that in light of its evolving policy concerning Outsourcing Facilities and its recent publication of 503B GMP Guidance, FDA may have elected to be less aggressive with the outsourcing sector’s inspections. I can only speculate. It might be outsourcers getting better, it might be a “lower bar,” it might be a bit of both, or it might be neither. All I can be certain of is that outsourcing inspections appear to be becoming more manageable over time.
Regarding their Amended 483, the only edit I could detect between their 483 on 12/17 and the Amended 483 on 12/18 is that the earlier one reflected a single Investigator (Linda Thai) and the Amended 438 reflected two FDA personnel (Linda Thai and Mariza M. Jafary, Compliance Officer (Region/District)). (*Note – I believe a Compliance Officer is higher ranking than a CSO)
Medcraft, LLC of Mounds OK (503B) was issued an FMD-145 Letter on 1/30/2019 in follow up to the 483 issued one 7/27/2018, at the end of the entity’s initial FDA inspection.
Intrathecal Compounding Specialists, LLC of Scott, LA was issued its second 483 on 2/14/2019. Its first 483 was issued on 11/17/2017, but not followed as yet by a WL. The current 483 was milder. Five Observations were recorded by a single investigator who was on site for what appears to have been four days and who typed the entity as a Producer of Sterile Products. The five included (1) construction or repair of ceiling HVAC without adequate cleaning and recertification afterward; (2) inadequate pressure differentials between rooms of different air qualification; (3) inadequate or infrequent use of sporicidal agents; (4) inadequate media fills; and (5) exposed skin inside the ISO 5.
Drug Crafters, L.P. of Frisco, TX was issued an SBoP Referral Letter on 2/11/2019 in reference to its 483 issued on 7/11/2017.
CSRX Inc (DBA Rushmore Compounding Pharmacy) of Rapid City, SD was issued an FMD-145 Letter on 2/19/2019 in reference to its 483 issued on 7/15/2016.
Lifetime Value Pharmacy III Inc. of Santa Ana, CA was issued a 483 2/21/2019. Nine Observations were recorded by a single investigator who was on site for seven days and who typed the entity as a “Compounding Pharmacy.” The Observations included:
- Inadequate evaluation and remediation after actionable microbial contamination was found in ISO 5;
- Inadequate glove disinfection/changing;
- Inadequate evaluation and remediation after actionable microbial contamination was found in an area adjacent to the ISO 5;
- Stains, splatter, and “uncleanable porous foam material” within ISO 5;
- Inadequate donning of gowning apparel;
- Unsealed ceiling tiles in the ISO 7;
- Non-sterilized and Non-depyrogenated equipment used in sterile drug production;
- Non-microbial discoloration/dried fluids/white fiber/scuff marks in the production area;
- Facility design allowed the influx of lesser quality air into higher quality air (air-blowing hand dryer inside the ISO 8)
- CBI Compounding Pharmacy Compliance Conference
- On June 19 and 20, I am slated to speak at the CBI Compounding Pharmacy Compliance program in Silver Spring, MD. My topic is entitled, “A Review of 483s and Warning Letters — Effective Response Strategies.”
- I think they will be a terrific slate of speakers there, that I think will include Dr. Ian DeVeau from FDA.
- The voucher below should drop your registration price down to $899 if you enter the discount code of FXJ884 at the appropriate prompt on the enrollment form (www.cbinet.com/compounding).
- I hope you decide to come! If you decide to attend, I hope you’ll let me know so that we can plan some one-on-one time.
- BioScrip and Option Care to Merge
- The two companies have executed a definitive agreement to merge their operations in an all-stock transaction
- The combined entity will be managed by Option Care’s CEO, John Rademacher and Option Care’s CFO, Mike Shapiro
- Madison Dearborn Partners and Walgreens Boots Alliance, (which currently own Option Care) will have a significant ongoing interest in the combined entity.
- CAR-T Point of Care
- I have often written in this newsletter about my deep interest in cellular and tissue therapies. I’m including an article today from Outsourcing-Pharma.com that explains Lonza has reached an agreement with Sheeba Hospital in Israel to beta-test the production of genetically-engineered CAR-T cells at the point of care. In 2013, Clark Byrum told me that HCT/Ps would ultimately be produced where the patients were receiving care and it looks like that time may be here.
- If successful, this will be a quantum leap toward bringing HCT/Ps to local communities. If it’s not successful, they will try again. I included a hyperlink if you want to take a glimpse into the future.
- Vasopressin – an Excellent Summary and Overview
- STAT published an excellent overview of the issues surrounding the right to sell vasopressin and I linked it in the bottom section.
- We’ve discussed the recent recent publication by FDA in the Federal Register which informed us that – if and when the 503B Bulks List ever gets published – vasopressin and nicardipine hydrochloide will not be on it. This contorted position was probably FDA’s effort to convince Endo to drop their lawsuit against the Agency that alleged FDA wasn’t doing its job to protect approved products from competition from unapproved sources.
- The STAT article states that Athenex (a 503B ROF) filed a suit from the opposite point of view and that FDA has agreed not to take action against the company until their lawsuit has been settled. (I searched for a hyperlink to the lawsuit’s Filing Document, but without success.) The STAT article states that BakerDaniels is representing Athenex in the suit.