Title: Serial Release -�s for APHIS Fonn 2008s 

Release Date: 20 May 2021 ---- Document Number: CVB-Wl-0158.03 

USDA 

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Center for Veterinary 

Biologics 

1920 Dayton Avenue 

PO Box 844 

Ames, IA 5001 0 

(515) 337�100 

CONTROLLED//PROPIN//BASIC 

Serial Release - Hold Management Process for APHIS Form 2008s 

Document Number: CVB-WI-0158 Revision: 03 

Previous Number: ICWI0810.04 

Vault: CYB-Released 

Section/Area: CVB-WI-IC 

Effective Date: 20 May 2021 

Notes: 

. on 24 May 2021, 06:13:33 pm. 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100 
Title: Serial Release - Hold Manag

ement Process for APHIS Fonn 2008s 

Release Date: 20 May 2021 ■ Document Number: CVB-Wl-0158.03 

CONTROLLED//PROPIN//BASIC 

Serial Release - Hold Management Process for APHIS Form 2008s 

Source Document: CVB-SOP-0032, Processing Serial Records 

-a 

The Hold Management process is one method for Inspection and Compliance (IC) to perform 

review of specific serials or products prior to authorizing release of the serial to the

marketplace. The reason for the Hold Action must be clearly documented. Hold Actions are

maintained within the LSRTIS module, under the Serial Release heading. The paper based

system was discontinued in Fall 2020.

Criteria for Legal Hold: Issues that are of regulatory in nature and have been communicated to 

the firm in writing that IC is withholding product from the market place. 

Criteria for Review Hold: Serial specific items, short term review (< 3 months), or those with 

specific release criteria (i.e., bench record review) should be considered. 

NOTE: Instead of a Review Hold, a user may also consider utilizing Mandatory 2008 Review. 

These may include: program diseases, items with a long term review hold (longer than 3-6 

months), and newly licensed products (for 1 year post licensure). 

Beginning in October 2019, duplicate entry of new Holds is not required. The official record will 

be within the LSRTIS System. 

A. Placing a Legal Hold - this is a regulatory action and as such requires written

notification to the firm. The notification is reviewed by the SL - Compliance prior to

placing the Legal Hold information into LSRTIS. It is considered an informal license

suspension.

1. Specialist enters data into LSRTIS through Serial Release - Hold Management, +Create

Serial Hold

2. Add appropriate information for the legal hold. A hold can be placed at the Establishment

level, Product Code, Antigen Fraction level or for a specific serial. In addition, multiple

holds are allowed, if the release criteria is the same.

a. Choose Legal from pull-down list

b. Establishment

c. Product( s)

d. Serial( s)

■ Leave blank unless the serial number is specific DO NOT enter "ALL".

e. Hold Reason: ( choose one)

■ Contamination-9 CFR 113.26, 113.27, 113.28, 113.30, 113.31, 113.32,

113.36,113.37, 113.42, 113.43, 113.46, 113.47, 113.50, 113.51, 113.52, 113.53,

113.55 or other applicable regulations related to purity of product

■ Unsatisfactory Testing-9 CFR 113.5, 113.6

■ Inspection -On-site inspection observations or actions which resulted in a

violation-cite regulation listed in inspection report

■ Expired Reference- 9 CFR 113.8(d)- use CVB-TEM-0015

■ Investigation-related to Veterinary Biologics Investigations (VBis)

■ Inactive Product License - 9 CFR 105.4 - use CVB-TEM-5107

CVB-WI-0158.03 

-n 24 May 2021, 06:13:33 pm. 

Contr y or Veterinary Biologics, 515-337-6100

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