FDA confirms that Catalent's war zone inspection results on Moderna boosters did not give grounds to stop them
Why has FDA turned soft on manufacturers???
You may remember this from last June:
FDA has been very prompt in its response, and as always been the case in my professional experience, they have been very honest and transparent. This is the response:
“Dear Hedley Rees,
Thank you for your inquiry. The Center for Biologics Evaluation and Research (CBER) is one of seven centers within the Food and Drug Administration (FDA). CBER is responsible for the regulation of biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, human cells, tissues, and cellular and tissue-based products (HCT/Ps), gene therapy and xenotransplantation products.
Your inquiry was forwarded from CBER’s Consumer Affairs Branch to CBER's Manufacturers Assistance and Technical Training Branch (MATTB) for response. We respond to general inquiries from industry. In the future, you may contact us directly at Industry.Biologics@fda.hhs.gov , or 240-402-8020. More on MATTB: https://www.fda.gov/vaccines-blood-biologics/industry-biologics/manufacturers-assistance-and-technical-training-branch-mattb.
The inspection at Catalent (09/01/2022) you mentioned in your inquiry, was concerning the project area of “Drug Quality Insurance.” You may review FDA’s Office of Regulatory Affairs (ORA) Field Leadership Contacts webpage, https://www.fda.gov/about-fda/contact-ora/ora-field-leadership-contacts. ORA’s Office of Pharmaceutical Quality Operations (OPQO) contact information is included on this webpage.
Additional information:
Inspection Classification Database and Search: FDA Data Dashboard for Inspection Classification data. You can review inspectional information concerning Catalent Indiana, LLC here: https://datadashboard.fda.gov/ora/firmprofile.htm?FEIi=3005949964&/identity/3005949964 .
Inspection Observations, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations
The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
ORA FOIA Electronic Reading Room, https://www.fda.gov/about-fda/office-regulatory-affairs/ora-foia-electronic-reading-room.
Pharmaceutical Inspections and Compliance, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance
How FDA Evaluates and Ensures Compliance
FDA’s Office of Regulatory Affairs (ORA) Investigations Operations Manual, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual.
Chapter 5 – Inspections
I hope this information is helpful.
Sincerely,
Stacey Rivette
Consumer Safety Officer
Manufacturers Assistance and Technical Training Branch
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Tel: 240-402-8020 or 800-835-4709
Industry.Biologics@fda.hhs.gov
About FDA Form 483s
It used to be, say 10 years or more ago, that issuance of a Form 483 to a manufacturing company sent shivers down the spine of executive management—and that was when the nature of the observations were rather more sanguine than they are today.
The Catalent 483 that I asked the question about was reminiscent of a war zone, and this is the comment from above:
The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
To take no action at the top level of FDA is deeply troubling.
I will be back with more news with this and MHRA/EMA responses in the next day or so.
FDA...what a putzy agency.
Post this on X, please.