if you all came across this type of FDA issue before, actually it is not a big issue lah. Dont over excited about it. One think I need to say is American is still human and human made mistake........understand....
For American, there are many option, Comfort is just another "kucing kurap" glove company. Since medical glove is related to "life & death", FDA might not show any tolerance. Good luck. I loss and deleting it my favorite list.
How am I notified that my product has been detained?
FDA notifies the responsible parties that an imported product violates FDA laws and regulations by issuing a "Notice of Detention and Hearing.” The Notice of Detention and Hearing provides a “respond by” date for the importer, owner, and/or consignee to provide FDA with evidence, also called testimony, to overcome the appearance of a violation. The Notice of Detention and Hearing will provide the sections of the laws and regulations that appear to be violated; these are referred to as charges.
after ding dong and FDA releases their detained product, the shipment to the customer will be delayed. This involves breach of trust and possible future sales.
But it is also a good opportunity for you to load up if you believe the company can pull it off this stunt.
Comfort is under FDA automatic detention level 1 which is a serious matter. That mean all containers entering USA are automatically detained. The owner has to conduct a third party inspection lab to carry out the testing procedure to prove the gloves meet the USA standard before it can be released.
very easy settle one, just issue an announcement to the bursa informing shareholders at large then settle d....if fda is a huge issue, just confess it, include statement that you're trying hard to get it thru, then shareholders can trust u.
From this case shows that this company is totally not trustworthy. You never see other local big players in FDA alert list and all the cases happened back to year 2009. Management certainly owes shareholders an explanation why company not comply to regulation?
i was told that this FDA inspection criteria very loose one. If kena detect, means something wrong with their process or system or they do hanky panky things behind. That's why this type of company always neglect the importance of quality system and take shortcut only. Serve them good this time.
New IPO: Building management systems (BMS), solar thermal systems and energy-saving services provider, Solar District Cooling Bhd aims to list on the Ace Market!
This book is the result of the author's many years of experience and observation throughout his 26 years in the stockbroking industry. It was written for general public to learn to invest based on facts and not on fantasies or hearsay....
Meng
118 posts
Posted by Meng > 2018-04-05 14:56 | Report Abuse
ok, so i feel disappointed that management keep quite all this while. will surely ask them explain in coming agm