Inspection Tools – Requested Documents and Observations

CONTROLLED//PROPIN//BASIC

CVB-WI-0074.02 Page 1 of 3

Issue Date: 21Dec23

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

Source Document: CVB-SOP-0035, Inspection: Inspection Process Activities

REQUESTED DOCUMENTS – CVB-FRM-0096

It is customary to request numerous documents for review during an on-site inspection. Form 

CVB-FRM-0096, Inspection, Requested Documents Worksheet, facilitates tracking what 

documents have been requested, received, and reviewed. This worksheet is considered part of the 

inspections notes. Each team member’s CVB-FRM-0096 will be attached to the Mail Log for the 

inspection report and can be used to prepare subsequent inspections for the site. 

PROCESSES OBSERVATIONS – CVB-FRM-0095

During the on-site inspection, the inspectors may observe the firm performing various steps of 

production. CVB-FRM-0095, Inspection, Processes Observed Worksheet, facilitates

documenting these observations. This worksheet is considered part of the inspection notes. Each 

team member’s CVB-FRM-0095 will be attached to the Mail Log for the inspection report and 

can be used to prepare subsequent inspections for the site. 

These forms can be either hand-written or electronic (pdf fillable form). If electronic, please print 

and add to handwritten notes. If hand-written, scan and add to Mail Log. 

Guidelines for each document:

1. Inspection, Requested Documents Worksheet – CVB-FRM-0096

Each field may or may not be applicable to the specified request. If not applicable, mark the field 

as NA. If an item does not relate to one of the below fields, use the next best associated field.

a. Rqst Date – Date the inspector requested the document from the firm

b. Rcv’d Date – Date the inspector received the requested document from the firm

c. Document name – General term for the request or Specific Document Name (i.e., Testing 

Bench Records or Egg Accountability and Use Record)

d. Document ID – If the firm has a specific name (ID #) for the document (i.e., CVB-FRM0096)

e. P. Code/Fraction – Specify the product code, if finished product, or fraction if bulk lots or 

Seeds/Cell records
Inspection Tools – Requested Documents and Observations

CONTROLLED//PROPIN//BASIC

CVB-WI-0074.02 Page 2 of 3 

Issue Date: 21Dec23 

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

f. Serial/Lot # - Specify the Serial # if finished product, or Lot # if bulk lots or Seeds/Cell 

records

g. Room # - if records pertain to specific rooms, such as cleaning records or autoclave 

records, document the room and building. 

h. Pg # (review) – for reference to inspector’s notes that document review – suggest using 

the date of the notes and then the page number. For example, 9/23, 4 represents notes 

taken on Sept. 23rd, listed on page 4.

i. Toggle box – to indicate review complete

2. Inspection, Processes Observed Worksheet – CVB-FRM-0095

a. Date – Date of the observation 

b. Process Observed – specify the production step (i.e., filling) 

c. P. Code/Fraction – specify the applicable product code for final product, or fraction for 

bulk or seed/cell production step

d. Serial/Lot # - Specify the Serial # if finished product, or Lot # if bulk lots or Seeds/Cell 

records

e. Room # - Specify the room and building # for where the production step occurred

f. Pg # (review) – Specify the pages of applicable note pages where the inspector’s 

observations are documented. Suggest using the date of the notes and then the page 

number. For example, 23/4 represents notes taken on the 23rd, listed on page 4. 

3. If you utilize the electronic version of these documents and create more than one page during 

the inspection, you can merge the two documents by the following steps: 

a. Save each page separate 

b. Open the left hand tab – “Page Thumbnails”

c. Choose the icon – “Insert page from another file” 
Inspection Tools – Requested Documents and Observations

CONTROLLED//PROPIN//BASIC

CVB-WI-0074.02 Page 3 of 3 

Issue Date: 21Dec23 

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

d. Select the file you saved previously – then choose “Open” 

e. You will be asked where to insert the page – choose the location and click OK

f. Resave.