After the 483 Form that we previously discussed is responded to by the outsourcing facility, the FDA has the option to then send an FDA Warning Letter if they’re not satisfied with the response and/or action plan that’s presented to them. In March of 2019 the FDA issued such an actual Warning Letter to Infusion Partners LLC located in Canfield, Ohio (Please note that Infusion Partners, LLC is actually part of the BioScrip Inc. “family”, BioScrip being the largest independent national provider of infusion and home care management solutions in the country, with over seventy locations across the USA).
What Actually Transpired With Infusion Partners to Warrant an FDA Warning Letter?
Beginning on January 22nd of last year, the U.S. Food and Drug Administration (FDA) investigators inspected the Infusion Partners facility that’s located at 4137 Boardman-Canfield Road, Suite L104, in Canfield, Ohio. They spent almost four full days observing the operation’s procedures and staff routines and left on January 26th of 2018. The FDA investigators documented what they considered to be “serious deficiencies” in the policies and practices for the manufacture and production of sterile medications and drug products by the outsourcing facility, which they deemed “put patients at risk”.
Pursuant to the inspection, the FDA issued a 483 Form to the facility and acknowledged the receipt of the facility’s two responses (dated February 15, 2018 and August 8, 2018). Based on the initial inspection observations and the facility’s responses, the FDA concluded that they were not satisfied and that Infusion Partners was producing medications and drug products that violated the Federal Food, Drug, and Cosmetic Act (FDCA).
What Does the FDA Warning Letter Actually Say and Include?
On March 20th of 2019, the FDA’s Division of Pharmaceutical Quality Operations issued an actual Warning Letter to Infusion Partners. You can click here to actually view the Warning Letter to Infusion Partners in its entirety, but let’s take a quick look at several of the important points noted by the FDA within the actual Warning Letter.
- Even though it is labeled simply as a Warning Letter, the reality is that the FDA actually opens what’s called a “Case” against the facility receiving the letter. In this example the Case number is #575451 and everything is published openly on the FDA’s website. Anyone can easily follow the case and watch how the process works as this case progresses in the future.
- The FDA included a specific list of the violations of the FDCA that they had observed during their inspection. This list basically matches the initial 483 Form that was previously sent, but now specified that the facility was “accused” of preparing and distributing what the FDA classified as “Adulterated Drug Products”. The FDA investigators noted that “drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the products to be adulterated under section 501(a)(2)(A) of the FDCA”. The Warning Letter then listed five (5) specific issues that had been observed and documented during the inspections, such as deficiencies in the actual design of the ISO 5 area, problems with the HEPA Filter itself, plus poor aseptic technique practices by the facility’s staff.
- Also included in the Warning Letter was a review of the “Corrective Actions” already taken and/or proposed by Infusion Partners in their two responses to the 483 Form. However, in three (3) separate violations, the FDA found the facility’s corrective actions and/or their future plans aimed at corrective actions to be inadequate. Once again, reading the actual Warning Letter may help an owner or manager better comprehend the level of detail that the FDA is documenting during their inspections and the extent of actual changes that they are requiring to be initiated at compounding pharmacies and outsourcing facilities throughout the USA.
What Happens Next Now That Infusion Partners Has Received an FDA Warning Letter?
It’s extremely clear that the message that the FDA is sending is simple: They are seriously letting everyone know that patient and consumer safety is their primary goal and that they intend to continue (and perhaps even intensify) their efforts to make compounding pharmacies and outsourcing facilities throughout the nation strictly adhere to “Best Practices” in all areas of their operations.
The Warning Letter is also extremely clear regarding what the FDA expects Infusion Partners to do next:
– They expect a written response to the Warning Letter within fifteen (15) days of receipt by Infusion Partners. They expect a detailed plan of the specific steps that have already been taken by the facility to correct existing violations, plus an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
– If the corrective actions cannot be accomplished within fifteen (15) working days, they require a detailed explanation of the reasons for the delays, plus a proposed date and time-frame which the facility will meet to complete the corrective actions required.
– They stress “Prompt Action”! They point out very clearly that the failure to promptly correct these violations “may result in legal action without further notice, including, without limitation, seizure and injunction”.
It must also be noted that the FDA places the burden of not only fixing the problems that they documented during their observation and inspection, but that it is in their view the facility’s responsibility to investigate and prevent the occurrence of any other violations in the future. As they clearly stated to Infusion Partners within their Warning Letter: “It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations”.
Lastly, it’s important to note that the FDA strongly recommends that all facilities initiate and undergo a comprehensive assessment of their facility’s current operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. As the FDA actually states: “A third-party consultant with relevant sterile drug production expertise should assist you in conducting this comprehensive evaluation”.
About Healthcare Consultants
Healthcare Consultants has been known as a national leader in pharmacy consulting for over 30+ years now. Since 1989, our network of experienced pharmacy consultants and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with pharmacies of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.
One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.
We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.