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FDA USE ONLY DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Date Received: BIOLOGICAL PRODUCT DEVIATION REPORT Date Reviewed: BPD ID: BPD No. * Indicates required information.

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The biological product deviation codes are used to categorize the deviation or unexpected event. The use of these codes will assist the FDA in analyzing the data submitted and streamline the trend analysis process. The product codes are used to identify the product(s) affected.

Biologics Product Categories Blood & Blood Products. Cellular & Gene Therapy Products. Tissue & Tissue Products. Vaccines. Xenotransplantation. Biologics Products & Establishments.

Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.

Reports should be submitted to CDERDQRSREPORTS@fda.hhs.gov using FDA Form 3486. To facilitate prompt processing of all incoming BPDRs, CDER strongly recommends that all information relevant to the BPDR be submitted in the FDA Form 3486.

Biological Product Deviation Reporting (BPDR) CBER Contact Information.

What is a biological product? Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

A deviation is a measured difference between a normal or expected value and an observed value for a pharmaceutical product or process. It can also be a noted departure from a documented or standard procedure. These deviations can happen during manufacturing, sampling and testing, or during product acceptance.

A “deviation” in manufacturing is when manufacturing steps are changed in some way from the set guidelines. Production guidelines are very detailed based on supply contract specifications, product design requirements, quality control and so on.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232