FDA starting new Enforcement Sweep

[LSRFAQ]

In what is a highly unusual move for the Agency, CDRH sent the following link via email to every Varienced Laser Show User in the USA

A friend forwarded me the email..

Here is the gist of the letter in a web link:

https://www.fda.gov/MedicalDevices/...485beae&elqaid=1172&elqat=1&elqCampaignId=680

Steve..

 

[Down with Umbrella]

Ouch, burn. The FDA calling out specific companies.:spank: Furthermore they noted Laserworld seemed reluctant to make hardware modifications. I don't own a projector but thanks for posting.

 

[Encap]

In what is a highly unusual move for the Agency, CDRH sent the following link via email to every Varienced Laser Show User in the USA
A friend forwarded me the email..
Here is the gist of the letter in a web link:
https://www.fda.gov/MedicalDevices/...485beae&elqaid=1172&elqat=1&elqCampaignId=680

Steve..

Seems pretty straight forward--FDA laid it all out pretty clearly--apparently the cat and mouse game of non-compliance by Laserworld has been ongoing and going on since 2013 and Laserworld has had many multiple second chances but chose to not resolve the problems FDA pointed out probably because they are large and established in many Countries and /or don'y care for whatever reasons what the FDA says, thinking they will get away with whatever forever.

FDA says: "Since September 2013, the FDA has worked with and taken action against Laserworld. Some of these actions include a face-to-face meeting and correspondence with Laserworld, a recall, a warning letter, issuing an import alert, and denying Laserworld’s request for variance (FDA approval that allows a manufacturer to deviate from a required performance standard). Laserworld’s responses to these actions have been incomplete and have not sufficiently addressed FDA’s safety concern"

Is a longstanding battle with Laserworld--nothing new.
See 2014 warning letter:https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438367.htm
FDA says: "On January 30, 2017, Laserworld’s manufacturing facility in Lake Mary, FL, was inspected by FDA. The inspection determined that Laserworld’s quality testing program was ineffective and incapable of certifying that their products comply with the Federal performance standard for laser products. Before the inspection could be completed, Laserworld closed the Lake Mary location."

So rather than comply Laserworld simply closed the Lake Mary FL location effectively running away from the FDA.
Is one way to skin a cat but not the wisest of choices. lol

I wonder what the next steps by FDA will be......? They stopped short of saying any variance holding laser show user who continues to buy and/or use Laserworld light show laser prducts will be subject to having their variances revoked and will be fined for any violations on a case by case basis---although they implied that is where it might be heading.