Idorsia Product Quality Complaint Form

We strongly encourage you to report any PRODUCT QUALITY ISSUE OR PROBLEM related to one of our products. Please report your PRODUCT QUALITY COMPLAINT using the following form.

If this is an emergency, please contact your local healthcare provider immediately

Complaint Information

Please enable JavaScript in your browser to complete this form.

Country of Occurrence

The country from which the TPC was reported

Date of Occurrence

Date in which the defect occurred.

Description

A detailed description of the defect and related information.

Product Information

Product

Select the reported product

Formulation

Dosage type i.e. tablet, capsule, vial, pre-filled syringe

Strength

This information can be found on the product container.

Lot Number

This information can be found on the product container.

Expiration Date

This information can be found on the product container.

Sample Available?

Can the reporter provide the sample, for further investigation, if requested?

Picture Available?

Can the reporter provide a picture of the product for investigation?

Product Administered?

Has the product been administered before the quality issue was discovered

Reporter Information

Consent to Contact?

Captures whether the reporter has consented to be contacted

Reporter Type

Select from the pick-list the most appropriate description

Reporter Firstname

Firstame of the Complainant (person who reported the complaint to Idorsia)

Reporter Lastname

Lastname of the Complainant (person who reported the complaint to Idorsia)

Reporter Email

At least TWO (2) forms of contact details for the Initial Reporter, such as email address, phone number, fax number and postal address

Reporter Phone

At least TWO (2) forms of contact details for the Initial Reporter, such as email address, phone number, fax number and postal address

Reporter Address

At least TWO (2) forms of contact details for the Initial Reporter, such as email address, phone number, fax number and postal address

Reporter Fax

At least TWO (2) forms of contact details for the Initial Reporter, such as email address, phone number, fax number and postal address

* I understand this form is not for reporting potential adverse events. To report suspected adverse events online, click here. To speak with someone directly, contact Idorsia at 833- 400-9611 or the Food and Drug Administration at 1-800-FDA-1088 or www.fda.gov/medwatch.

Idorsia retains your personal data to address or provide a reply to your medical information inquiry. In processing your personal data, Idorsia will fully comply with internationally recognized standards of data protection. In doing so, Idorsia ensures compliance of its staff with strict standards of security and confidentiality. Additional information on the processing of personal data and the exercise of rights related to your personal data can be found in Idorsia’s Privacy Policy