Ignoring Inspection Results doesn't pay off

Recommendation

4/5 October 2022
Heidelberg, Germany

Process Validation in the light of the revised Annex 15 and FDA Requirements

After an FDA inspection with relevant results, the FDA usually expects a response within 15 days. What happens, however, if there is no response?

A South Korean company experienced that after not responding to an FDA inspection result. They received a Warning Letter and were placed on Import Alert. And the inspection deficiencies were indeed severe. Amongst other things, there was no validation of analytical methods, no cleaning validation and insufficient stability data. Neither was there any process validation or continued process verification. Due to these deficiencies, the FDA recommended for the company to engange a consultant.

Please read the complete FDA Warning Letter to Nowcos Co.