Prior to this Coronavirus mess, we had several of our foreign clients scheduled for inspections by the FDA. then everything came to a halt and the FDA investigators were basically on a home lock down. The FDA had always had the authority to request company information under the section 704(a)(4) of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 USC 374(a)(4).

Recently we had our first request by the FDA for one of our foreign clients to fill out FDA form 4003 in lieu of their on-site visit. The company was taken by surprise and now is trying to determine how to respond.

The FDA goes on to state that, any records or other information that may be inspected under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, shall be provided by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner. This can be done in either electronic or physical form. Upon the receipt of these records requested, a confirmation will be sent. Nothing stated in this section supplants the authority to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter. If the records requested do not exist, please state that fact in your response.

For more information, please see the FDA Staff Manual Guide 9004.1: Policy and Procedures for Requesting Records in Advance of or in lieu of a drug inspection.

Any other information posted will be updated by mdi to our clients. If you have any other questions please email [email protected] RE: Inspections.