Johnson Creek company welcomes FDA regulation of e-cigarettes

[mpetva]

Johnson Creek company welcomes FDA regulation of e-cigarettes

http://online.wsj.com/article/SB10001424052748704644404575481770842414954.html

 

[plaidness]

Read the article. Question. What violations did Johnson Creek commit? I have read several articles regarding the FDA letters and haven't seen that explained.

 

[Vocalek]

You can read the full text of the letter yourself. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm

Here is an ECF post by Andtyler2 regarding the portion of the letter relating to "violations" regarding the production process.

As for JC, I'm waiting for them to weigh in here or elsewhere. According to the letter the FDA sent JC, that "failed inspection" wasn't particularly recent; it took place a year ago.

From the FDA:

Additionally, during our September 1-25, 2009, inspection of your manufacturing facility, . . . investigator(s) from the FDA identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals . .

.

Hard to believe the FDA would sit on that information for a year before sending them a formal warning. Must be more to the story?

So....did the FDA ever bother to mention these "shortcomings" to Johnson Creek management any time during the past year? If not, then they must not be very seriously impacting product quality.