FDA hits China Plant - OTC DRUG Nationwide Recall

[AnaMariaVR2]

Jiangsu Province Jianerkang Medical Dressing Co. 7/30/12
http :// www. fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314565.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

OTC DRUG Nationwide Recall --Important Information About Benzalkonium Chloride Antiseptic Wipes
http ://www .fda. gov/Safety/Recalls/ucm313912.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

510K summary
http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112110.pdf

 

[Mikishots]

Re: FDA hits China plant

Jiangsu Province Jianerkang Medical Dressing Co. 7/30/12

OTC DRUG Nationwide Recall --Important Information About Benzalkonium Chloride Antiseptic Wipes
http :// www. fda.gov/Safety/Recalls/ucm313912.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

510K summary
http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112110.pdf

Wowzer. I've seen a bunch of these letters before, but this one is a big one.

 

[paulag]

Re: FDA hits China plant

Is a compilation on the outcomes of FDA inspectioned chinese plants available anywhere?