What happens when an FDA letter turns on a contract manufacturer, not the drug?

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.

Verrica Pharmaceuticals Form 8-K, filed September 20, 2021

announced that it received a complete response letter from the U.S. Food and Drug Administration (the “ FDA ”) identifying deficiencies at a facility of a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The identified deficiencies do not specifically relate to the manufacturing of VP-102, but instead raise general quality issues at the facility. The FDA did not identify any clinical, safety or product specific chemistry, manufacturing, and controls deficiencies related to the NDA.

Verrica Pharmaceuticals Form 8-K, filed September 29, 2021

Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid products

Verrica Pharmaceuticals Form 8-K, filed November 12, 2021

On November 5, 2021, Verrica was notified that the inspection of the CMO has been classified as “voluntary action indicated” (“VAI”), is now closed and that the VAI classification will not directly negatively impact FDA’s assessment of the Company’s NDA regarding this CMO. With the satisfactory resolution of the facility inspection, Verrica has engaged the FDA to determine the next steps toward the potential approval of VP-102 for the treatment of molluscum.

Verrica Pharmaceuticals Form 8-K, filed May 25, 2022

announced that it received a complete response letter (“ CRL ”) from the U.S. Food and Drug Administration (the “ FDA ”) as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceutical Services, LLC (“ Sterling ”), a contract manufacturing organization for its New Drug Application (the “ NDA ”) for VP-102 for the treatment of molluscum contagiosum. The CRL did not identify any other deficiencies. Sterling advised the Company that it received notice on May 19, 2022 that it is on Official Action Indicated (“ OAI ”) status. None of the issues identified by FDA during the reinspection were specific to the manufacturing of VP-102. The Company was informed by the FDA that it had completed its review of the NDA and product label, there were no open questions on the NDA review, and the VP-102 label was ready to be communicated.

FDA Complete Response Letter, August 4, 2022 · page 2

During a recent inspection of the and Rovi Pharma Industrial Services S.A (FEI 3016688535) manufacturing facilities for this application, our field investigators conveyed deficiencies to the representatives of the facilities. Satisfactory resolution of these deficiencies is required before this application may be approved.

CorMedix Form 8-K, filed August 9, 2022

has entered into an agreement with Alcami Corporation, a US based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products, which will serve as an alternative manufacturing site for DefenCath. The Company has been working with Alcami over the past several months to transfer the manufacturing process for DefenCath into an Alcami site, and CorMedix expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023.

CorMedix Form 8-K, filed August 9, 2022

CorMedix has supported the efforts of the CMO to compile robust responses and corrective action plans to inspectional observations the CMO received during the FDA’s recent pre-approval inspection of the CMO for the DefenCath NDA. The FDA has not yet advised the CMO of the post-inspection compliance classification, but CorMedix will continue to provide any needed support in the upcoming weeks as the CMO completes implementation of all necessary corrective actions.

CorMedix Form 8-K, filed August 9, 2022

A second Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA. There were no other deficiencies related to DefenCath cited in the CRL, and the Company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath NDA.

CorMedix Form 8-K, filed August 9, 2022

Separately, the FDA conducted a recent inspection unrelated to DefenCath at the facility of the company’s heparin supplier, which culminated in the API supplier receiving a warning letter as a result of manufacturing deficiencies for a non-heparin API. CorMedix sought guidance from FDA as to whether these deficiencies would impact the timing of approval of the DefenCath NDA, and by way of the CRL, the FDA has now informed the company that satisfactory resolution of these deficiencies will be required before the DefenCath NDA may be approved. The Company’s heparin supplier has advised CorMedix that it has retained an independent CGMP consultant to expedite the implementation of corrective actions and resolve the warning letter as quickly as possible.

Verrica Pharmaceuticals Form 8-K, filed August 11, 2022

Verrica has begun working with Piramal Pharma Solutions to manufacture bulk solution for VP-102 at their Sellersville, Pennsylvania site. Verrica will continue to work closely with Piramal and the FDA to facilitate a timely technology transfer and production quality at the facility.

Verrica Pharmaceuticals Form 8-K, filed August 11, 2022

Verrica announced that it held a Type A Meeting with the FDA regarding the path forward for the resubmission and potential approval of the NDA for VP-102 for the treatment of molluscum. The FDA indicated a willingness to work collaboratively on the amount of stability data required from an alternative CMO for the bulk solution of VP-102 at the time of resubmission as well as options for post-approval use of bulk solution previously manufactured.

CorMedix Form 8-K, filed March 30, 2023

CorMedix announced an agreement to validate manufacturing of DefenCath at Siegfried AG’s site in Hameln, Germany, which has previously been inspected by FDA. The Hameln site previously manufactured Neutrolin®, which was sold in Europe as a medical device. The Company intends to utilize Siegfried as a back-up CMO.

CorMedix Form 8-K, filed April 26, 2023

At the Type A meeting, the FDA informed CorMedix that it is in receipt of the close out report for inspectional observations received from its existing contract manufacturing organization (“CMO 1”), and NDA resubmission with CMO 1 can be done at the Company’s discretion. The FDA may conduct a pre-approval inspection at the facility as part of the NDA review process.

CorMedix Form 10-K, filed March 5, 2026

In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier.

CorMedix Form 10-K, filed March 5, 2026

The Company received FDA approval of DefenCath with finished dosage production from its European based CMO Rovi Pharma Industrial Services. In addition, the Company also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling production at the facility.

Verrica Pharmaceuticals Form 10-K, filed March 11, 2026

On July 21, 2023, YCANTH (VP-102) (cantharidin) 0.7% topical solution was the first product approved by the FDA for the treatment of molluscum in adult and pediatric patients two years of age and older. We commercially launched YCANTH (VP-102) in August 2023 in the United States for the treatment of molluscum.

Verrica Pharmaceuticals Form 10-K, filed March 11, 2026

On June 6, 2022, plaintiff Kranthi Gorlamari, or Plaintiff, filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against 69 Table of Contents us and certain of our current and former officers and directors, or Defendants. On January 12, 2023, the Plaintiff filed an amended complaint alleging that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval of YCANTH (VP-102) for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Plaintiff and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022, or the Putative Class Period.