What action would the FDA consider as obstructing an inspection?

The FDA views failing to produce requested records in a timely manner as obstructing an inspection because it directly impedes the agency's ability to carry out its responsibilities in reviewing a facility’s compliance with regulations. Timely access to records is essential for inspectors to evaluate the safety, efficacy, and quality of products being manufactured. When the required documentation is not provided as requested, it delays the inspection process and prevents FDA officials from obtaining a comprehensive understanding of the operations being evaluated. This hinders their ability to ensure that the establishment complies with applicable laws and regulations, which is critical for public health and safety.

On the other hand, providing incomplete documentation, while problematic, may not be considered outright obstruction, as it may still allow for some level of review. Not allowing inspectors to meet staff can also be serious but may not always be viewed as obstructive if alternative means of communication are available. Changing the inspection date, while it can cause scheduling difficulties, does not necessarily impede the inspection itself if proper notice is given and a new date can be arranged without significant delays.