Common FDA 483 Observations for Combination Products

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology, Regulatory Sourcebook, March 2022, Volume 2022 eBook, Issue 1
Pages: 10–15

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

Combination products are considered combinations of a device, drug, biologic, or human cells, tissues, or cellular or tissue-based products (HCT/P) and are regulated by FDA under Code of Federal Regulations (CFR) 21 Part 4, Regulation of Combination Products (1). The guidance states that drugs, biologics, HCT/Ps, and devices—as constituent parts of a combination product—are required to conform to the current good manufacturing practice (CGMP) regulations pertaining to each constituent part. The guidance also identifies the specific CFR sections for each applicable part.

Due to the complexity inherent in combination products, it is probable that drug sponsors will receive several deficiencies and compliance observations (known as 483 observations in the United States). That is why awareness of how regulatory authorities view method validation and what the common observations are will help sponsors minimize their regulatory risks.

Read this article in Pharmaceutical Technology's March 2022 Quality and Regulatory Sourcebook eBook.


This is part two in a series. Read part one: A Method Validation Framework for Combination Products.

About the author

Adam Lambert, PhD, is the VP, product and process development, for Pharmatech Associates, a USP company.

Article details

Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2022
Pages: 10–15


When referring to this article, please cite it as A. Lambert, "Common FDA 483 Observations for Combination Products," Pharmaceutical Technology's Quality and Regulatory Sourcebook eBook (March 2022).