Replies to post #18404 on SiNtx Technologies Inc (SINT)

[XenaLives]

Found link to FDA inspection report below.

Now if they are in the process of retooling, would this create a delay in resolution of these issues?

Warning - I know squat about these issues...

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm609054.pdf

[boston745]

The Warning Letter states that requests for Certificates to Foreign Governments will not be granted until the violations have been corrected. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. We presently have no such applications before the FDA.

Finally some info as to whats impacted

Warsaw is their their main manufacturing and R&D hub. What all they manufacture at this specific location I cant say but they should produce all their main products here based on the employee count. They employ about 1/3 their manufacturing staff at this location, 2700/7900.

9,700 employees are located outside of the U.S., primarily throughout Europe and in Japan.

Zimmer has a largish presence in Japan from the looks of this.