ROTC:Rotech medical Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : ROTC:Rotech medical

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

To: kathy jo card who wrote (62)	5/7/1997 2:10:00 AM
From: waverider	of 161

Anyone have any comments about this? It came out today. Diamond H The Food and Drug Administration has issued a warning letter to Rotech Medical Corp. because of its failure to ensure that compressed medical oxygen it distributed met specifications. The letter, dated April 14, states that the company didn't make sure that the medical oxygen met guidelines for identity and strength. The company also failed to maintain any records for the transfilling of compressed medical oxygen. There also was no indication, the FDA said, that Rotech adhered to any of the regulations for drug products. The warning letter also states that during an inspection of the Georgia facility, Rotech management didn't mention that it was transfilling medical oxygen for distribution, which Rotech later admitted in an affidavit. It's a federal offense to knowingly and willfully make false statements to a government agency. Rotech officials were given 15 days to respond to the warning letter. If the violations aren't corrected, the FDA states it may issue an injunction to seize company products without further notice.

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next