Fillable LIFE SCIENCES PRODUCT RECALL SUPPLEMENTAL APPLICATION (Kinsale Insurance)

Fill Online, Printable, Fillable, Blank LIFE SCIENCES PRODUCT RECALL SUPPLEMENTAL APPLICATION (Kinsale Insurance) Form

Use Fill to complete blank online KINSALE INSURANCE pdf forms for free. Once completed you can sign your fillable form or send for signing. All forms are printable and downloadable.

LIFE SCIENCES PRODUCT RECALL SUPPLEMENTAL APPLICATION (Kinsale Insurance)

On average this form takes 43 minutes to complete

The LIFE SCIENCES PRODUCT RECALL SUPPLEMENTAL APPLICATION (Kinsale Insurance) form is 6 pages long and contains:

  • 1 signature
  • 30 check-boxes
  • 152 other fields

Country of origin: US
File type: PDF

Use our library of forms to quickly fill and sign your Kinsale Insurance forms online.

BROWSE KINSALE INSURANCE FORMS

Related forms
Fill has a huge library of thousands of forms all set up to be filled in easily and signed.
Fill in your chosen form
Sign the form using our drawing tool
Send to someone else to fill in and sign.
find another form
 
Page 1 of 6
LIFE SCIENCES PRODUCT RECALL SUPPLEMENTAL APPLICATION
COMPLETE IN ADDITION TO ACORD APPLICATIONS.
ATTACH ADDITIONAL SHEETS AS NECESSARY.
ANSWER ALL QUESTIONS. If not applicable, indicate N/A.
1)
Named Insured:
Brokerage/Broker:
Agency/Agent:
Renewal? Yes No
Policy Number:
Effective Date:
Website:
2) Current Carrier Information:
Carrier:
Recall Expense?
Yes No
Recall Liability?
Yes No
Cutoff Date:
Deductible:
Premium:
Offering renewal?
Yes No
Please attach copies of the following:
a) Currently valued five-year General Liability/Product Liability and Recall loss runs, and loss details for any
recalls outside of coverage history. If you have had a recall, complete the Kinsale Product Recall Claim
Supplement and include copies of all governmental agency documents for all recall claims and any applicable
court documents
b) Product brochure, catalog, or marketing materials if a website is not available
c) Current policy declarations page for cutoff date (if applicable)
d) Copy of your current recall plan, quality assurance/product testing protocols and methods, HACCP plan,
SSOP/GMP plans, etc. as applicable to your operations
3) Mailing address:
Address:
City: State: Zip Code:
4) Premise address:
Address:
City: State: Zip Code:
Kinsale Insurance Company
P. O. Box 17008
Richmond, VA 23226
(804) 289-1300
www.kinsaleins.com
Page 2 of 6
5) Years you have been in operation and selling products of the type for which you are seeking coverage:
6) Total sales of products for which coverage is being sought for the coming year: $
7) Projected number of units sold for which coverage is being sought for the coming year:
8) If you are seeking recall coverage for specific products only, please list them:
9) Have you ever had a product recall? If yes, please complete and attach the Kinsale Yes No
Recall Claim Supplement and copies of all pertinent government documents.
10) Are any of your products presently under investigation, by yourself or any other entity or Yes No
government authority, for a possible defect, flaw, contamination or other issue which may give
rise to a product recall? If yes please attach details.
a. Have you had any customer complaints about specific product(s)? If yes, attach details. Yes No
11) Do you carry General Liability (GL) or Products/Completed Operations (PRCO) liability insurance Yes No
for your products?
12) Have you had any product liability claims within the last five years? Yes No
a. If yes, how many?
b. If you have had multiple claims, did they involve the same or very similar products? Yes No
c. Has any product design changed as a result of claims? Yes No
13) What type of product are you selling? Check all that apply:
Pharmaceuticals or Pharmaceutical Ingredients Nutraceuticals or Nutraceutical Ingredients
Veterinary or Livestock Pharmaceuticals, Nutraceuticals or Pharmaceutical/Nutraceutical Ingredients
FDA Class I Medical Devices Blood, Organs or Tissues – Human Use
FDA Class II Medical Devices Blood, Organs or Tissues – Animal Use
FDA Class III Medical Devices Cosmetics or Skincare Products or Ingredients
Veterinary or Livestock Medical Devices or Medical Supplies
14) What is the nature of your sales? Check all that apply:
Direct to consumer
Business to Business – Complete/Packaged Goods for Sale
Business to Business – Complete/Packaged Goods for Business Use
Business to Business – Ingredients
15) If you are not seeking coverage for a specific product(s) identified in 8) only, please complete the below for your
top five products:
Product
Total sales
Average lot/batch size
Percentage of sales
Page 3 of 6
16) How many products are in a normal batch or lot number?
17) In addition to your internal testing/quality control measures, are your products tested by any Yes No
independent 3rd parties or government authorities?
a. List testing agency or firm(s):
b. How frequently is this testing done?
18) Do you outsource any parts, components, or ingredients for your product? Yes No
a. If yes, are any parts, components, or ingredients imported? Yes No
b. If yes to a., what percent? %
c. Do you track or maintain records of lot or batch numbers of sourced materials and the Yes No
corresponding lot or batch of your products in which they have been incorporated?
d. Have any of your suppliers ever notified you of a recall? Yes No
e. Do any suppliers grant you indemnification for product recall? Yes No
f. If yes to e., do you collect certificates of insurance (COIs) confirming AI status? Yes No
19) If you are selling business to business, do you provide any of your customers indemnification Yes No
or hold harmless agreements relating to product recall?
20) How frequently are all processing, production, packing or other handling lines:
a. Cleaned?
b. Maintained/Mechanically Serviced?
c. Shut down for deep sanitization?
21) Do you handle or process any common allergens (nuts, dairy, soy, etc.) in any of your facilities? Yes No
a. If yes, does your labeling notify of possible contamination?
b. Do you source from suppliers who may reasonably be assumed to handle common allergens? Yes No
22) Are your products subject to any government agency or authority labeling regulations? Yes No
23) Please check the federal agencies’ rules and authority under which your products are subject to regulation:
Food and Drug Administration (FDA) United States Department of Agriculture (USDA)
Consumer Product Safety Commission (CPSC) Center for Biologics Evaluation and Research (CBER)
Other: Center for Devices and Radiological Health (CDRH)
24) What is the shelf life of your products?
a. If your product is an ingredient/additive of another company’s product, does the final Yes No
product have the same shelf life as your product? If no, please clarify:
25) Have you ever been subject to a criminal tampering/intentional adulteration incident? Yes No
If yes, please attach details and a copy of any applicable police reports.
26) Have you ever received a violation notice from the FDA or other similar agency that did not Yes No
result in a recall? If yes, please attach a copy as well as any follow up reports, re-inspections,
and the corrective action plan implemented.
27) Do you do your own research and development or formulation? Yes No
a. If no, are formulations provided to you by your client or customer? Yes No
Page 4 of 6
b. Please describe the qualifications of and any professional designations held by the person or persons
responsible for product formulation:
28) Do you track reported adverse effects or other customer complaints? Yes No
a. If yes, how long are these records retained?
b. Are incidents always reported to the FDA Adverse Event Reporting System (FAERS)? Yes No
29) Do you sell biosimilars of FDA approved products which are not themselves approved? Yes No
30) Are any of your products frequently prescribed for off-label use for which they are not approved? Yes No
a. If yes, please clarify:
31) Are any of your products considered homeopathic, ayurvedic or otherwise alternative Yes No
medicine in nature?
32) Have any of your products ever been permanently removed from the market or banned from Yes No
sale? If yes, please list:
33) Do you sell any cannabis products? Yes No
a. Are products cannabidiol (CBD) only, compliant to United States H.R.2 - Agriculture Yes No
Improvement Act of 2018, Title X, Subtitle G – Hemp Production?
b. Are all products tested for concentration and contamination by an independent 3rd Yes No
party or state assigned laboratory? If yes, please attach a copy of your last testing results.
c. Are product labels reviewed by legal counsel? Yes No
d. Do any product labels speak to medical conditions or intended therapeutic usage? Yes No
34) Do you have dedicated staff monitoring CBER updates to biologics guidance? Yes No
a. Please attach a copy of your screening questionnaire and guidelines as applicable.
b. How frequently are your donor guidelines and screening procedures updated?
35) Have you or any of your suppliers ever been subject to increased FDA inspection of your facilities? Yes No
a. If yes, please attach additional information and a copy of your corrective action plan.
36) Do you sell cadaver organs or tissues? Yes No
37) Do you sell living donor organs or tissues? Yes No
38) Do you sell blood, organs or tissues for laboratory use only? Yes No
39) Do you sell any medical devices outside of the US which are banned or have otherwise been Yes No
removed from the market by the FDA (prosthetic hair fibers, polypropylene breast implants,
powdered surgical gloves, etc.)?
a. If yes, what?
40) Do you participate in the FDA Voluntary Malfunction Summary Reporting Program? Yes No
41) Have you ever had an FDA form 3500A mandatory reporting event? Yes No
a. If yes, has the device involved had any subsequent failures of malfunctions of a similar type Yes No
Page 5 of 6
in another patient or patients?
b. If yes, please attach details.
42) Are any of your products possibly subject to cybersecurity vulnerabilities (hacking or other Yes No
unauthorized access, electromagnetic pulse sensitivity, programming errors)?
a. If yes, how frequently are devices tested for emerging cyber threats?
b. How are healthcare providers and patients alerted to firmware updates and vulnerabilities?
FRAUD WARNING
NOTICE TO ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, CONNECTICUT, DELAWARE, GEORGIA, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS,
MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NORTH CAROLINA,
NORTH DAKOTA, OREGON, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TEXAS, UTAH, VERMONT, WASHINGTON, WEST VIRGINIA, WISCONSIN,
AND WYOMING APPLICANTS: In some states, any person who knowingly, and with intent to defraud any insurance company or other person, files an
application for insurance or statement of claim containing any materially false information, or, for the purpose of misleading, conceals information
concerning any fact material thereto, may commit a fraudulent insurance act which is a crime in many states.
NOTICE TO COLORADO APPLICANTS: It is unlawful to knowingly provide false, incomplete or misleading facts or information to an insurance company for
the purpose of defrauding or attempting to defraud the company. Penalties may include imprisonment, fines, denial of insurance and civil damages. Any
insurance company or agent of an insurance company who knowingly provides false, incomplete or misleading facts or information to a policy holder or
claimant for the purpose of defrauding or attempting to defraud the policyholder or claiming with regard to a settlement or award payable for insurance
proceeds shall be reported to the Colorado Division of Insurance within the Department of Regulatory Agencies.
NOTICE TO DISTRICT OF COLUMBIA APPLICANTS: WARNING: It is a crime to provide false or misleading information to an insurer for the purpose of
defrauding the insurer or any other person. Penalties include imprisonment and/or fines. In addition, an insurer may deny insurance benefits if false
information materially related to a claim was provided by the applicant.
NOTICE TO FLORIDA APPLICANTS: Any person who knowingly and with intent to injure, defraud or deceive any insurance company files a statement of
claim containing any false, incomplete or misleading information is guilty of a felony of the third degree.
NOTICE TO HAWAII APPLICANTS: For your protection, Hawaii law requires you to be informed that presenting a fraudulent claim for payment of a loss or
benefit is a crime punishable by fines or imprisonment, or both.
NOTICE TO KENTUCKY APPLICANTS: Any person who knowingly and with intent to defraud any insurance company or other person files an application for
insurance containing any materially false information or conceals, for the purpose of misleading, information concerning any fact material thereto commits
a fraudulent insurance act, which is a crime.
NOTICE TO LOUISIANA APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or knowingly presents
false information in an application for insurance is guilty of a crime and may be subject to fines and confinement in prison.
NOTICE TO MAINE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose of
defrauding the company. Penalties may include imprisonment, fines, or denial of insurance benefits.
NOTICE TO NEW JERSEY APPLICANTS: Any person who includes any false or misleading information on an application for an insurance policy is subject to
criminal and civil penalties.
NOTICE TO NEW MEXICO APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or knowingly presents
false information in an application for insurance is guilty of a crime and may be subject to civil fines and criminal penalties.
NOTICE TO NEW YORK APPLICANTS: Any person who knowingly and with intent to defraud an insurance company or other person files an application for
insurance or statement of claim containing any materially false information, or conceals, for the purpose of misleading, information concerning any fact
material thereto, commits a fraudulent insurance act, which is a crime and shall also be subject to a civil penalty not to exceed $5,000 and the stated value
of the claim for each such violation.
NOTICE TO OHIO APPLICANTS: Any person who, with intent to defraud or knowing that he/she is facilitating a fraud against an insurer, submits an application
or files a claim containing a false or deceptive statement is guilty of insurance fraud.
Page 6 of 6
NOTICE TO OKLAHOMA APPLICANTS: WARNING: Any person who knowingly, and with intent to injure, defraud or deceive any insurer, makes a any claim
for the proceeds of an insurance policy containing any false, incomplete or misleading information is guilty of a felony.
NOTICE TO PENNSYLVANIA APPLICANTS: Any person who knowingly and with intent to defraud any insurance company, or other person, files an application
for insurance or statement of a claim containing any materially false information or conceals for the purpose of misleading, information concerning any fact
material thereto commits a fraudulent insurance act, which is a crime and subjects the person to criminal and civil penalties.
NOTICE TO TENNESSEE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose
of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
NOTICE TO VIRGINIA APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose
of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
The Applicant acknowledges that the answers provided herein are based on a reasonable inquiry and/or investigation. The Applicant warrants that the
above statements and particulars together with any attached or appended documents are true and complete and do not misrepresent, misstate or omit
any material facts.
The Applicant agrees to notify us of any material changes in the answers to the questions on this questionnaire which may arise prior to the effective
date of any policy issued pursuant to this questionnaire and the Applicant understands that any outstanding quotations may be modified or withdrawn
based upon such changes at our sole discretion.
Completion of this form does not bind coverage. Applicant’s acceptance of the company’s quotation is required prior to binding coverage and policy
issuance.
All written statements and materials furnished to the company in conjunction with this application are hereby incorporated by reference into this
application and made a part of this application.
Applicant: Title:
FEIN #:
Applicant’s Signature: Date:
Agent/Broker Name:
click to sign
signature
click to edit
Download
Save PDF to desktop
Email
Email completed PDF
Send for Signing
Email for others to sign
Print
Print document
Choose a Field
Click on a field and
select the person that should complete it
Want to add a signature?
You can add a signature field
and assign it to someone else
to sign
Choose a Field
Click on a field and
select the person that should complete it

LIFE SCIENCES PRODUCT RECALL SUPPLEMENTAL APPLICATION (Kinsale Insurance)

This document is locked as it has been sent for signing.

You have successfully completed this document.

Other parties need to complete fields in the document. You will recieve an email notification when the document has been completed by all parties.

This document has been signed by all parties.

Completed 31 January 2021

Message

View Audit Log
Print With Audit Log
Duplicate Document