Rules,...What Rules? Update

  Closed...so soon, or what?

 

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One done... 

Home office permit has been issued.

 

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More to go... 

Comfort Lining Inc. and its owner Jennifer Watson are:

☑ under the Florida State Attorney General’s Office Florida Statutes violation investigation:

For falsely claiming her business entity as Comfort Lining Inc. while it isn’t really incorporated.

For manufacturing medical device in violation of Florida Drug and Cosmetics Act.

For hiring employees without complying with Employer Worker’s Comp requirement

☑ under the FDA Code Enforcement Office investigation:

For not complying with GMP requirements set forth in accordance with CFR 21 Parts 808, 812 and 820.

 

☑ under the IRS Employer Requirements violation investigation:

For hiring employees without obtaining a Federal Employer Identification Number.

Rules,...What Rules?

Rules,…What Rules?

Jennifer Watson/Comfort Lining

Master of Rule Breaking

They are now:

☑ under the St. Johns County, FL zoning code violation investigation:

For manufacturing and distributing her products out of the residential area not authorized to conduct those business activities.

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☑ under the Florida State Attorney General’s Office Florida Statutes violation investigation:

For falsely claiming her business entity as Comfort Lining Inc. while it isn’t really incorporated.

For manufacturing medical device in violation of Florida Drug and Cosmetics Act.

For hiring employees without complying with Employer Worker’s Comp requirement

                                        Click on image to enlarge

☑ under the FDA Code Enforcement Office investigation:

For not complying with GMP requirements set forth in accordance with CFR 21 Parts 808, 812 and 820.

☑ under the IRS Employer Requirements violation investigation:

For hiring employees without obtaining a Federal Employer Identification Number.

                         Opening a Pandora's box indeed!

Home Free?.....Not So Fast

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While 510k is exempt GMP (Good Manufacturing Practices) regulatory requirement under 21 CFR 820 is not exempt and still need to be fully complied with. 

GMP

https://en.wikipedia.org/wiki/Good_manufacturing_practice

GMP Regulations

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Remember I am not a lawyer but I hold an honorary JD from the University of Street Smart Chicago.

Now who is bullying whom?

   Now who is bullying whom?     

   Just the facts, ma’am.  

This post was removed from the Denture Living Forum site by its biased draconian moderator whose action caused to lose some of the other worthy contributors in disgust.

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                          Now who is bullying whom?  Just the facts, ma’am.