FDA Posts Notice stating a Change in Procedure for Certain Human Drug Compounding Facilities

September 6, 2016
After input from stakeholders the FDA posted a notice announcing a change in inspections of 503 (A) Human Drug Compounding Facilities effective August 1, 2016. The investigations will consist of an initial assessment to see if the pharmacies are operating as a 503 (A) facility. If it is concluded that the facility is not operating as a 503 (A) facility the investigator will place the pharmacy on the list of non-compliance 483 and require the pharmacy to meet CGMP requirements. “The FDA investigators now will make a preliminary assessment regarding the firms compliance with certain conditions of section 503A before closing an inspection” as a response to the stakeholders input.
View Our Work
Explore Cleanroom Photo Gallery
How Can We Help?
We'd love to answer any question you might have. Drop us a line and we'll get back to you shortly!
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.