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FDA Inspections - what do they look for?


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#1 kishor1988

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Posted 12 February 2016 - 05:42 AM

Dear all,

              We are manufacturing acidified foods in India and exporting to US. Now FDA want to inspect our manufacturing facility. Please guide what they will look. please share anybody having checklist and guidelines.

 

 

Regards,

kishor 



#2 luna_blue

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Posted 12 February 2016 - 07:34 AM

Hi,

 

The FDA auditors will focus more on cleaning & sanitation and allergen control / management.

 

Cheers



#3 Mandark

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Posted 12 February 2016 - 08:22 AM

Hi Kishor, please check 21 CFR 114 (acidified foods), 21 CFR 110 (CGMP) or click this link for more information on related FDA Guidelines, https://www.gpo.gov/...ent-detail.html

 

Regards.

Sierwin



#4 Maltus

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Posted 18 February 2016 - 01:10 PM

Kishor, if you produce canned food, they will check specially your sterilization process control. And at least one worker should have the BPCS certification.



#5 3esa

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Posted 18 February 2016 - 03:51 PM

Pre-requisite programs they check routinely:

- Cleaning & Sanitation

- Pest Control

- Training

- Water Monitoring

- Food Defense

 

Then HACCP.  You're doing acidified foods, they'll check that you're records are in order, verified, and that your kill step has been validated and your HACCP plan is validated.

 

They'll likely ask about your suppliers and who your customers are.



#6 3esa

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Posted 18 February 2016 - 06:33 PM

they're also big on traceability and will ask to see your recall policy.

 

Good luck!






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