Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

10. Unsatisfactory or Unmarketable Serials
LSRTIS > Reports & Searching > APHIS 2008 Search
Enter: Est. #
APHIS Disposition: Test Completed UNSATISFACTORY and/or
Other — UNSATISFACTORY Based on Firm’s
Results
and/or Other — Serial NOT RELEASED FOR
MARKET
Action Timestamp: From date of last inspection to today

This search should be used as preparation tool. Reminder, most serials initially marked as
not to be marketed have additional history, and the disposition may be changed based on
additional information. All serials in these categories should be researched prior to the
inspection.

REMINDER - Serials marked “Tests Completed Unsatisfactory” and in some cases the
other two dispositions above may require CVB to observe the destruction.

11. Internal Doses Report (this is only a pdf report)
LSRTIS > Reports & Searching > Reports > Internal Doses Produced
Enter: Est. #
Enter From Date: Date of Last Inspection
Enter To Date: Today’s Date
Click on PDF

This report lists the number of serials and doses released to the marketplace per product
code. It also shows which products have had serials destroyed by the firm. It should be
used in preparing for serial audits of specific products. It is advised to audit a product
which is produced often and also a product that is not prepared as often. It is best not to
choose the same product codes as audited in previous inspections unless there were
significant issues.

12. Most Recent Release Date

LSRTIS > Reports & Searching > Reports > Most Recent Serial Release Date by Firm
Enter: Est. #
Status: Active

This information can be used to look for inactive products (products not released in the
last 5 years). But if a serial of an active license has not been released in LSRTIS (since
November 2011), this product code will not show on this report. It is a deficiency in this
report that is scheduled to be fixed by April 2017. Also, the report is a pdf and does not
sort by any discernable means. In its current state, it is not the most useful report but has
nuggets of information. It can be used to ensure annual outline of production (OP)
reviews are being done even for product that has not been recently released.

13. Serials Received — another way to search for information listed under #9 and #10
LSRTIS > Serial Release > Serial Search

Enter: Est. #

With an Action of: Aphis 2008 Logged In

Action Timestamp: From date of last inspection to today

CVB-WI1-0076.02 Page 4 of 7

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Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

18.b. Export Documents Audited
LSRTIS > IC > Exports
Enter: Est. #
With an Action of: Audited
Action Timestamp: From date of last inspection to today

This can provide insight regarding control of review, both for the information on the
export document and perhaps Outline review.

18.c. Export Documents for Product Licenses with an Export Distribution
Restriction
Step 1 — LSRTIS > Licensing > Product Licenses
Enter: Est. #
License Status: Active
Restriction: 46 — Export distribution....
Step 2 - LSRTIS > IC > Exports
Enter: Est. #
Product (as found above): Product Code
Type: Aphis 2017
With an Action of: Signed by Specialist
Action Timestamp: From date of last inspection to today

This should provide a listing of some serials to review for compliance with the export
distribution restriction. Any serials/inventory exported to other countries must have
written authorization from the proper animal health official from the receiving country.
This may be in the form of a registration or certificate from the receiving country.

18.d. Export Documents For Further Manufacture products
Step 1 — LSRTIS/Licensing > Product Licenses

Enter: Est. #

License Status: Active

Restriction: 51- For Further Manufacture
Step 2 - LSRTIS > IC > Exports

Enter: Est. #

Product (as found above): Product Code

Type: Aphis 2017

With an Action of: Signed by Specialist

Action Timestamp: From date of last inspection to today

This should provide a listing of serials to review for compliance with distribution of the
FFM product. The Outline of Production Section VI lists acceptable recipients of the
FFM product. Alternatively, PEL may have provided written authorization to export
product to locations other than what is listed in the OP. This most likely is on a one-time
basis.

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Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

Status: Active Inventory

For both Master Seeds and Master Cells, using the date listed in “Approval Date(s)”
column can provide you information on newly approved seeds and cells. This may be a
good place to ensure the inventory is correct (near the beginning of use).

Another search option is entering the regulatory status as “Disapproved.” You may have
to research why as this is not always clear in the Seed or Cell record. Knowing where this
“disapproved” inventory is and its use may show control in the prelicensing functions.

8. Licensing Plan

LSRTIS > Licensing > Licensing Plans
Enter: Est. #
License Status: Prelicensing

The licensing plan is a useful tool. It lists parent product (if applicable), seeds and cells,
risk analysis (if applicable), manufacturing process, Efficacy/Kit Sensitivity-Specificity,
Safety/Kit field trial, Testing, Prelicensing Serials, and Other. The applicable ML are
listed. The Reviewer Synopsis can also be helpful. While we can get this information
from the ML, the Licensing Plan has it all in one place.

9. List of APHIS Form 2008s (2008s) Received
LSRTIS > Reports & Searching > APHIS 2008 Search

This search can be done in several ways to target specific information or use the Excel
spreadsheet to sort for specific information.

Serials Signed by Specialist
Enter: Est. #
With an Action of: APHIS 2008 Signed by Specialist
NOTE: Can be left blank to see all serials submitted.
Action Timestamp: From date of last inspection to today

Missing Serials — found because there is a 2008 but no samples
Enter: Est. #
Click “Has No Samples”
Serial Status: Active
Action Timestamp: From date of last inspection to today
Reminder — 2008s submitted for Reprocess & Retest are not expected to have samples.
Also, if the firm uses sequential numbering to assign serial numbers, you may be able to
see this in a listing and ask about any missing numbers.

Release Requirements
Enter: Est. #
Click “Release Criteria Required?”
Action Timestamp: From date of last inspection to today
This is helpful to ensure they are meeting the expectation related to marketing release.
Check and see if the completion date was done to double check the firm’s compliance.

CVB-WI1-0076.02 Page 3 of 7

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

This will give you a complete listing of 2008s submitted to CVB for review and
processing. You may want to sort Active vs. Complete.

14. Samples
LSRTIS > Sample Processing > Sample Search
Missing Serials — Sample submitted but no corresponding 2008
Enter: Est. #
Click “Has No APHIS 2008?”
Action Timestamp: From date of last inspection to today

This can be a great area to find issues, including on-going process deviations. There are
times a sample is submitted prior to the full QA review or there are issues with testing.
These are highlighted by this listing. Be aware of the date received as samples recently
received may have been submitted in accordance with concurrent testing and there are no
issues. The flag is samples received 2-3 months (or more) from the date the report is run
if testing does not include a lengthy animal test.

Sample Submission Issues

Enter: Est. #

Click “Was Rejected?”

Action Timestamp: From date of last inspection to today

This may be an indication of lack of control or if the firm has requested samples be
rejected, there may be a larger issue.

15. Inspection Action Items
LSRTIS > IC > Inspections
Go to Pending Action Items Tab
In Search Field, Type Est. #
Review these action items prior to the inspection.
If no action items are still pending:
Go to Action Item Search
Enter: Est #
You can focus on the priority by selecting Serious or Less Serious

Review the action items that are pertinent to the site you are inspecting. Being aware of
older action items is helpful in preparing for the current inspection.

ALWAYS read the last inspection report. Suggest reading the last two or three reports, if
available.

16. Inspection Items to Consider
Mail > Search > Master Search
Enter: Est. #
Mail Log Tags: Inspection Items to Consider

The reports do provide a brief comment, but this search should be done in preparation for
the inspection as you may need to talk to the CVB individual who tagged the ML item if
it is not apparent what the concern is. Try to get as many specific details as possible as to

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Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation

Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

IC Pre-Inspection Packet Checklist - LSRTIS Information and

Preparation

Document Number: CVB-WI-0076 Revision: 02
Previous Number: ICWI0041.04

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 10 Sep 2020

Notes:

Printed by: CRHERR on 17 Sep 2020, 10:59:07 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

what the issue may be or what is suspected. It may just be following up on a request
made.
NOTE: general statements are not helpful for inspection purposes.

This will also be used as a method to follow up on VBI information as the Investigation
and Compliance Specialist (ICS — Rick Dewald) will be tagging these Mail Logs.

17. Investigations
LSRTIS > IC > Investigations
Enter: Est. #
Click on “Is Not Closed?”

This list should be reviewed as a part of preparation for inspections. Additional
information or assistance can be provided by the ICS — Rick Dewald. For closed
investigations, the ICS will confirm inspection recommendations made in the Report of
Investigation are noted as Inspection Items to Consider.

18. Exports

Issuance of export certificates is a service we provide. Perceived misuse of these
certificates must be reviewed by the Inspection and Compliance Management Team
(ICMT) prior to determining any violation. In most cases, the observation may be an item
of concern. This tool is more to assist with an audit of a restricted license, labeling and/or
distribution and provide some information regarding the use of export certificates. Below
are several searches that can be used to determine compliance.

18.a. Export Documents Certified
LSRTIS > IC > Exports
Enter: Est. #
With an Action of: Finalized
Action Timestamp: From date of last inspection to today

The reports just provide a listing of type of certification [APHIS Form 2017 (2017) or
Certificate of Licensing and Inspection (CLI)] and destination country. The reports do not
provide product code or serial number, so this search should be used as a part of the pre-
inspection preparation. Information regarding individual certificates on the LSRTIS
screen do list type of certificate, products, and country. Using the “Show” button, you can
see more details, such as serial numbers and doses for 2017s. This information can be
used during an audit of distribution.

Go to the file room and review CLIs issued that include appended labels. Note the
product code and country.

When at the firm, request distribution records for serials of product to that specific
country. Review labeling records for one of the serials shipped to see what labels were
used. While there is no restriction on only using the label appended to the CLI, we should
understand why this label was submitted for certification and then NOT used. This is not
a violation, but may be an item of concern or perhaps a control/communication issue.

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Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

Pre-Inspection Packet Checklist — LSRTIS Information and Preparation

Source Document: CVB-SOP-0034, Pre-Inspection Activities

The order of the information listed below is not in priority order. Each report or search
should be considered as part of the preparation for inspection or as information required
while on inspection. LSRTIS/Mail Log (LSRTIS/ML) is a powerful information tool and
as we continue to use LSRTIS/ML, we will find better ways to search and sort
information for the purposes of inspection.

The information can be put in a pdf or Excel format. The information may be printed or
saved on the computer for use during the inspection. While we also can retrieve this
information while at the firms using our hotspot, there may be times in which there is
equipment issues — so don’t be left without any preparation material, carry a hardcopy or
save to your desktop.

1. Establishment Mgmt

LSRTIS > Licensing > Establishment Mgmt
Enter: Est. #
Export Profile

This provides overarching information about the firm.
¢ Portal Enabled
Mail Address
All Sites (for multi-site firms, including inactive)
Active USDA Employee Assignments
Reasons for Establishment License Reissue
e Mergers/Purchases
It can be long since it also lists active employees for the establishment.

2. Establishment Sites (for site you are inspecting)
LSRTIS > Licensing > Establishment Sites
Enter: Est. #
Status > Active
Pick “In State” if applicable to the inspection

This provides more site specific information, including the telephone number for the site.
Please note the Min Years Between Inspections and the Max Years Between Inspections.
If your inspection indicates a change to this inspection interval is needed, please inform
Section Leader, Inspection, when you return with the reason why.

3. Establishment Employees (List of APHIS Form 2007 on File with CVB)
LSRTIS > Licensing > Establishment Employees
Enter: Est. #
Site City or State (or both or neither)
Click on “Only Active Employees”
Click on “Only Active Employees for Establishment”

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Title: IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation
Release Date: 10 Sep 2020 Author: RSCHNURR Document Number: CVB-WI-0076.02
CONTROLLED//PROPIN//BASIC

The Excel spreadsheet is more beneficial for this listing as it is searchable on your
computer, but the pdf is cleaner. Currently, the pdf does not include the eauth user name.

4. Labels
LSRTIS > Licensing > Labels Search
Enter: Est. #

Label Status: Active
Click on “Only Active Licenses”
— note, this excludes any products in prelicensing
NOTE: Trade names are on this list.

Pay special attention to extended labels with expiration dates.

As a part of the pre-inspection preparation, you may want to run the report without
choosing a Label Status and indicating an expiration date for the last two years (or since
the last inspection). Auditing the “use” or inventory of these inactive/expired labels may
be a good way to test label control.

5. Product Licenses
LSRTIS > Licensing > Product Licenses
Enter: Est. #
License Status: Active
NOTE: Repeat this step with License Status as “Prelicense” and “FDA-EREA.”

For this report, the Excel spreadsheet has much more useable information.
When conducting pre-inspection preparation, note the following:
¢ Conditional Licenses will have an expiration date under “License Expiration
Date.”

o Are they continuing to make a diligent effort towards full licensure?

o Recently Policy, Evaluation, and Licensing (PEL) has not automatically
been re-issuing conditional licenses, especially when a fully licensed
product has been licensed by another firm.

¢ Chose at least one Biotech product for auditing, if possible.

e Ifthe date is not filled out in the “Expiration Dating Verification Date” column,
this may be a good product to review why. There may be many blanks, so choose
a product that has a high volume of released doses.

e Products containing FFM product are clearly listed. Use this to trace back to the
FFM

e¢ Combination packages are listed on this spreadsheet — encourage review of
packaging for these products — this may include review of Section V testing for
bacterins used as diluents.

6. Master Seeds
LSRTIS > Licensing > Master Seeds
Enter: Est. #
Status: Active Inventory

7. Master Cells
LSRTIS > Licensing > Master Cells
Enter: Est. #

CVB-WI1-0076.02 Page 2 of 7

Printed by: CRHERR on 17 Sep 2020, 10:59:07 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100