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FDA Warning Letter Evaluation and Response

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oacosta60

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Posted 02 December 2022 - 02:06 PM

Hi Everybody

 

Do anyone have experience charging: FDA Warning Letter Evaluation and Responses



Setanta

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Posted 02 December 2022 - 02:17 PM

Hi Everybody
 
Do anyone have experience charging: FDA Warning Letter Evaluation and Responses


I think there we'd need some more information in order to be helpful. What type of facility?
Do you want to Charge or Change the Letter?
What were the FDA findings, did you receive a Form 483?

-Setanta         

 

 

 


oacosta60

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Posted 02 December 2022 - 03:12 PM

Hi Setanta
 

Facility for Now are Food and Beverage Industry. 

 

Yes, I want to charge the letters and meetings with the FDA.

 

The companies have received 483’s and Warning Letters.

 

Findings are related with FSMA, Example: 21CFR117, 21CFR1 part L (FSVP), Mislabeling among others.

 

Our focus is Preventing and resolving compliance issues: We offer a diverse services:

 

Document Preparation/Reviews.

Developing effective systems to comply with the industry requirements.

Reviewing product labeling for regulatory compliance.

Providing technical writing for protocols, reports, specifications, policies, and procedures.

Compliance Problem Resolution.

Responding to an FDA 483 inspection.

Responding to an FDA Warning Letter.

Meeting with the FDA to resolve disputes if were necessary.

Implementing corrective and preventive action (CAPA) programs-including development, execution, and monitoring.

Trainings.

 Audits and Reviews.



Scampi

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Posted 02 December 2022 - 05:03 PM

oacosta------are you asking for help or are you selling your services?


Please stop referring to me as Sir/sirs


kingstudruler1

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Posted 02 December 2022 - 05:43 PM

You want to know what to charge for your consulting service?

 

https://www.ifsqn.co...ltant-charging/

 

What is your time worth?   it's up to you.    

 

since you used 483(S) and letter(s) in the plural, it sounds like a huge mess.    Good luck.   


eb2fee_785dceddab034fa1a30dd80c7e21f1d7~


oacosta60

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Posted 02 December 2022 - 06:11 PM

Scampi

 

I am asking for help.

 

Do anyone have experience charging: FDA Warning Letter Evaluation and Responses



oacosta60

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Posted 02 December 2022 - 06:20 PM

Thank you kingstudruler1

 

The place is really a mess.



Charles.C

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Posted 03 December 2022 - 12:29 AM

Hi Oscar,

 

I'm not a Consultant but It seems  "Big Mess" likely involves all your detailed  "diverse Services" so counts as a "Project". eg -

 

https://www.ifsqn.co...17/#entry191036

 

But also note the caveat in the fpllowing Post (12).


Kind Regards,

 

Charles.C




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