CorMedix · DefenCath · Mar 2021 – Feb 2022

How did CorMedix describe the FDA's first letter?

The March 2021 press release said the FDA had not specified the facility issues and had raised no efficacy or safety deficiencies. A year later, a company presentation said a pre-approval inspection could not be conducted due to the pandemic.

EphemerisX Research · Published October 7, 2026 · 4 source documents · 2 min read

Short answer

CorMedix's March 1, 2021 press release reported the facility concerns and the extraction study, said the FDA had not specified the facility issues, and said the FDA identified no deficiencies in the efficacy or safety data. It did not name the manufacturer. Its February 2022 presentation summarized the letter as calling for resolution of deficiencies at a facility where a pre-approval inspection could not be conducted due to the pandemic.

What the evidence shows

The press release: FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility 8-K · Mar 1, 2021. FDA did not specify the issues 8-K · Mar 1, 2021. The letter itself says the objectionable conditions will be conveyed to the representative of the facility within 10 business days of issuance of this Complete Response letter FDA · Feb 26, 2021 · p. 8. The letter names the facility as Rovi Pharma Industrial Services; Neither press release reporting a letter (March 2021, August 2022) names Rovi, the facility both FDA letters name. 8-K · searched

On the second item, the press release says the FDA was requiring a manual extraction study despite an existing in-process control to demonstrate fill volume within specifications 8-K · Mar 1, 2021. The letter: You have not demonstrated that the currently proposed in-process control FDA · Feb 26, 2021 · p. 9 is appropriate FDA · Feb 26, 2021 · p. 9, and As previously communicated to you, conduct and provide results of an extraction study FDA · Feb 26, 2021 · p. 9.

The press release adds: FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100 8-K · Mar 1, 2021. The searchable text of the two letters (one PDF) does not mention efficacy, effectiveness or the LOCK-IT-100 trial. One page of the February 2021 letter has no text layer and could not be searched. FDA · searched It also reports, from draft labeling discussed with the FDA, that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter 8-K · Mar 1, 2021. The 2025 10-K describes the approved product the same way: It is indicated for use in a limited and specific population of patients 10-K · Mar 5, 2026.

On inspections, the 2021 press release says If an inspection is required, the FDA is currently facing a backlog due to the pandemic 8-K · Mar 1, 2021. The February 2022 investor presentation summarizes the letter as indicating the need to resolve deficiencies at third - party manufactur ing facility, where a pre - approval inspection could not be conducted due to the pandemic 8-K · Feb 28, 2022. The letter's own words on an inspection are conditional: If it is determined that an inspection is needed to approve your application FDA · Feb 26, 2021 · p. 8.

What CorMedix reported doing next: What did CorMedix say it fixed before resubmitting DefenCath in 2022?

Follow the thread

What did the FDA's first letter on DefenCath require?“As previously communicated”: the extraction study
How did CorMedix describe the FDA's second letter?Neither press release names Rovi

This investigation connects to

What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, Outlook Therapeutics, Replimune, Verrica Pharmaceuticals
What happens when an FDA letter turns on a contract manufacturer, not the drug?Cross-investigation · Shared concern · with Verrica Pharmaceuticals
What did “no efficacy or safety issues” cover in these FDA letter announcements?Cross-investigation · Shared concern · with Replimune, Verrica Pharmaceuticals

The documents, by date

The passages quoted

FDA Complete Response Letter, February 26, 2021 · page 8

During a review of records requested under Federal Food, Drug, and Cosmetic Act section 704(a)(4), provided by Rovi Pharma Industrial Services S.A. (FEI 3016688535) manufacturing facility, the FDA noted objectionable conditions. These objectionable conditions will be conveyed to the representative of the facility within 10 business days of issuance of this Complete Response letter. Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection and/or adequate facility responses addressing these conditions) before this application may be approved.

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FDA Complete Response Letter, February 26, 2021 · page 8

If it is determined that an inspection is needed to approve your application, please note that FDA continues to monitor the public health situation as well as travel restrictions. We are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.

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FDA Complete Response Letter, February 26, 2021 · page 9

You have not demonstrated that the currently proposed in-process control for the ( mL± mL) in the drug product manufacturing process is appropriate. As previously communicated to you, conduct and provide results of an extraction study to demonstrate that the labeled volume of the drug product solution (5 mL) can be consistently withdrawn from vials, including vials that are . Revise the based on the results of the extraction study conducted.

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