Verrica Pharmaceuticals · VP-102 · Sep – Nov 2021
Why did the FDA's second letter turn on a contract manufacturer's facility?
Verrica said the deficiencies were general quality issues at a contract manufacturer's facility, not specific to VP-102. Seven weeks later the inspection was classified “voluntary action indicated” and closed.
EphemerisX Research · Published · 5 source documents · 2 min read
Short answer
Verrica's filings say the September 2021 letter turned on deficiencies at a contract manufacturer's facility that “do not specifically relate to the manufacturing of VP-102.” In November 2021 the inspection was classified “voluntary action indicated” and closed, and Verrica resubmitted on November 24.
What the evidence shows
The 8-K of September 20, 2021: The identified deficiencies do not specifically relate to the manufacturing of VP-102, but instead raise general quality issues at the facility.
8-K · Sep 20, 2021
The presentation filed nine days later says the letter came due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102
8-K · Sep 29, 2021. Verrica planned a Type A meeting to demonstrate that the Company’s good manufacturing practices, controls and processes ensure that any deficiencies at the CMO do not impact the efficacy, safety or quality of VP-102
8-K · Sep 29, 2021, and added: The CMO has also advised Verrica that it is expecting a satisfactory resolution of the facilities identified deficiencies from the FDA prior to the Type A meeting.
8-K · Sep 29, 2021
The same presentation lists Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid products
8-K · Sep 29, 2021.
On November 5, 2021, Verrica says, it learned 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
8-K · Nov 12, 2021. The chief executive: We are pleased that the issues identified at the CMO unrelated to VP-102 have been successfully resolved, enabling us to move toward approval
8-K · Nov 12, 2021.
Verrica resubmitted the NDA for VP-102 on November 24, 2021
8-K · Nov 29, 2021. None of Verrica's five 2021 filings on the second letter (September 20 to November 29) mentions Sterling. 8-K · searched The manufacturer is named after the next letter: What changed between Verrica's second and third FDA letters?
The letter's electronic signature is dated 09/16/2021
FDA · Sep 16, 2021 · p. 11; Verrica's November presentation says it received the letter from the FDA on September 17, 2021
8-K · Nov 29, 2021. The first page of the letter has no text layer in the FDA's published file, so the letter is quoted here only from its later pages.
Follow the thread
- What were the “Human Factor comments” the FDA's second letter said would follow separately?Resubmitted November 24, 2021
- What changed between Verrica's second and third FDA letters?“Voluntary action indicated”
- How did VP-102 get from a third FDA letter to approval in July 2023?“Limited commercial CMOs”
- What is the securities class action against Verrica about?“General quality issues at the facility”
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with Aldeyra Therapeutics, CorMedix, Outlook Therapeutics, Replimune
- What happens when an FDA letter turns on a contract manufacturer, not the drug?Cross-investigation · Shared concern · with CorMedix
- What did “no efficacy or safety issues” cover in these FDA letter announcements?Cross-investigation · Shared concern · with CorMedix, Replimune
The documents, by date
The passages quoted
FDA Complete Response Letter, September 16, 2021 · page 11
KENDALL A MARCUS 09/16/2021 02:20:43 PMOpen at the source →
Verrica Pharmaceuticals Form 8-K, filed September 20, 2021
None of Verrica's five 2021 filings on the second letter (September 20 to November 29) mentions Sterling.
Open the document →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.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed September 29, 2021
Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid productsOpen at the source →
Verrica Pharmaceuticals Form 8-K, filed September 29, 2021
Verrica received a Complete Response Letter (CRL) from the FDA in September 2021 due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102. The Company will request a Type A meeting with the FDA in Q4 ‘21 to demonstrate that the Company’s good manufacturing practices, controls and processes ensure that any deficiencies at the CMO do not impact the efficacy, safety or quality of VP-102. The CMO has also advised Verrica that it is expecting a satisfactory resolution of the facilities identified deficiencies from the FDA prior to the Type A meeting.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed November 12, 2021
We are pleased that the issues identified at the CMO unrelated to VP-102 have been successfully resolved, enabling us to move toward approvalOpen at the source →
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.Open at the source →
Verrica Pharmaceuticals Form 8-K, filed November 29, 2021
Verrica received a Complete Response Letter (CRL) from the FDA on September 17, 2021 due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102. The Company received a General Advice Letter (GAL) from the FDA on September 22, 2021 with recommendations to improve VP-102’s user interface. On November 5, 2021 Verrica was notified that the inspection of the CMO was 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. Verrica resubmitted the NDA for VP-102 on November 24, 2021; the resubmission is limited to address the successful resolution of inspection deficiencies identified at the CMO in the CRL, as well as the recommendations included in the General Advice Letter.Open at the source →