FDA also does not accept creative Arguments for Lack of Validation

In the GMP rules, there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case, it is about insufficient process validation. What happened?

It concerns a manufacturer of hand disinfectants in the USA, which fall under 21 CFR 210/211. In addition to several other deficiencies, the FDA complained about a lack of process validation of the products that are on the market. Very "creative" is the reason given by Custom Research Labs Inc. as to why validation was not carried out. They argue that they would need batches to be able to validate the formulation. However, only two batches have been fully manufactured so far, Custom Research Labs Inc. adds, but the FDA found several batches in distribution during their inspection. The FDA criticises that no evaluation or corrective action was taken by Custom Research Labs Inc. regarding the unvalidated products in distribution.

Furthermore, the FDA demands 

  • a detailed summary of the validation programme including the accompanying SOPs 
  • a description of the programme regarding Process Performance Qualification (PPQ) 
  •  a description of the Continued Process Verification 
  • timelines for PPQ for each product to be marketed, including a description of the measures taken to ensure that appropriate validation is in place before the products are marketed.

You can find the entire Warning Letter on the FDA website.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.