On May 30, 2018, Diana Amador, Program Division Director, Office of Pharmaceutical Quality Operations (OPQO), Division I, issued a letter to “Our Regulated Pharmaceutical Industry”.
This letter offers firms an opportunity to submit all FDA 483 responses in electronic format up to 100 megabytes. If files exceed 100 megabytes, they may be submitted as smaller files in additional emails.
OPQO established the following email address for submissions: ORAPharm1_responses@fda.hhs.gov.
In each email submission, the firm will be required to put their Firm Establishment Identifier (FEI) number and registered name in the subject line of the email.
As part of the text in the email the firm will need to include:
- The location(s) of the inspection
- Dates if the Inspection
- Names of FDA personnel conducting the inspection
OPQO will issue an acknowledgement email to the firm upon receipt on the submission. OPQO states that the responses will be “expeditiously” routed to the appropriate Agency personnel.
Firms will not be required proved hard copies to OPQO.
This new process should save trees and costs for firms deciding to use this process.
It may also allow for more time to create and vet data and information for responses.
If firms have questions, they can reach Diana Amador via email at Diana.Amador-Toro@fda.hhs.gov or via telephone at 973-331-4900.